types of symbols that could be used. Among the types of symbols
permitted was an FDA-proposed generic symbol.
    We received many comments (approximately 40) on this proposal. None
of these comments expressed support for the FDA-proposed generic
symbol. Many suggested that only specific internationally recognized
symbols should be permitted, and some suggested each issuing agency
should specify the symbols that would be used. Some comments went
further, and objected to the provision in its entirety; these comments
were primarily concerned that an AIDC symbol would crowd label space
and lead to confusion, particularly if the provision permitted
different labelers to choose different symbols.
    In response to these comments, FDA has simplified this provision,
now at Sec.  801.40(c), so that it requires that the label or device
package disclose the presence of AIDC technology without specifying
how. We deleted the authorized use of an FDA-proposed generic symbol.
We believe this approach addresses the concerns of device users that
the FDA symbol will crowd label space and be confusing or conflict with
other expectations of the issuing agency, while providing labelers
greater flexibility and reduced burdens.

V. Form of a Unique Device Identifier--Effect of Labeling a Class I
Device With a Universal Product Code--New Sec.  801.40(d) of the Final
Rule

    FDA has added this provision to explain that a class I device that
bears a UPC on its label and device packages is deemed to meet all
requirements of subpart B of this part; these devices will not have to
bear a UDI on their label or device packages and will not be subject

to direct marking requirements. The UPC will serve as the UDI required
by Sec.  801.20. The labeler of such a device is still required to
submit data concerning the device to the GUDID, unless the UPC device
also qualifies for the exemption under Sec.  801.30(a)(2) as a Class I
GMP-exempt device. Such devices are wholly exempt from UDI
requirements, including the requirement to submit data to the GUDID.

W. Changes to Codified Text in Response to Comments on Requirements
Proposed in Sec.  801.50--Devices That Must Be Directly Marked With a
Unique Device Identifier

    Requirements proposed in Sec.  801.50, concerning devices that must
be directly marked with a UDI, have been reorganized, modified, or
withdrawn, as follows:
     Sec. Sec.  801.50(a)(1) and (g)--Withdrawn.
     Sec. Sec.  801.50(a)(2), and (b) through (f)--Now at Sec.
801.45 of the final rule, which concerns devices that must be directly
marked with a UDI.
     Sec.  801.50(a)(3)--Now at Sec.  801.50 of the final rule,
which provides special requirements for stand-alone software.
    Because of these changes, comments submitted concerning proposed
Sec.  801.50 are discussed under the following four topics.

X. Devices That Must Be Directly Marked With a Unique Device
Identifier--Proposed Requirement for an Implantable Device To Bear a
Permanent Marking Providing the Unique Device Identifier on the Device
Itself--Proposed Sec.  801.50(a)(1)

    We received many comments (approximately 47) on this proposed
requirement, which would have required an implantable device to bear a
permanent marking providing its UDI on the device itself.
    Nine comments expressed support for the proposal; eight of these
comments expressed general support for the requirement; one other
comment recommended a more rigorous requirement, suggesting all devices
``that will be implanted for 24 hours or more'' should be subject to
direct marking (the definition of implantable device means a device
intended to remain implanted for at least 30 days). The remaining
comments opposed this requirement, identified obstacles that might
undermine the proposal, requested an exception, or suggested an
alternative that would have significantly limited the scope of the
provision. For example, one comment stated, ``direct marking of
implantable medical devices is a waste of both industry and FDA
resources'' and should not be part of the UDI rule. Other comments
stated, ``Direct labeling of implantable HCT/P devices . . . could
impact the safety of the device''; that small implants cannot be
directly marked without interfering with functionality; that direct
marking of an implant would be useful only if the device was explanted;
that the proposal is ``substantially redundant in effect'' with FDA's
Medical Device Tracking Requirements, 21 CFR part 821; and that a
patient's electronic health records will identify any implant. One
comment summarized these objections by stating, FDA should ``eliminate
the direct marking requirement for implantable devices,'' because there
are no ``discernible benefits to direct marking implantable devices
above and beyond those expected from the entire UDI system, while the
costs would be substantial.''
    FDA finds these comments opposing direct marking for implants to be
persuasive, and we are withdrawing the proposal for direct marking of
implantable devices. We believe that the UDI label and package
requirements will provide for adequate identification of an implantable
device up to the point where it is implanted. We also acknowledge the
common practice of recording information about implanted devices both
in the patient's health record, and on a card provided to the patient,
and we expect health care providers will incorporate UDIs into both of
these types of records. Further, we expect the use of EHRs and PHRs
will facilitate the documentation of implantation. Direct marking would
generally serve no purpose as long as the device remains implanted, as
there would be no way to read the direct marking except in those
instances where RFID technology could be built into the device. We
believe that the move to electronic health records, as well as any
records maintained under part 821 (device tracking), will provide
adequate alternative sources of information concerning any implanted
device, and any device that is explanted.
    A comment that presented policy reasons for removing the direct
marking requirement for implantable devices from the rule (which has
been removed from the final rule as discussed elsewhere in this
preamble) also argued that the FD&C Act does not provide FDA authority
to require direct marking of devices.
    FDA disagrees with this comment. As explained in the preamble to
the amended proposed rule, the direct marking of devices will enable
FDA to more efficiently and effectively respond to a reported device
problem by using its regulatory tools, such as notification or
mandatory recall under section 518 of the FD&C Act, tracking under
section 519(e), ensuring the adequacy of a voluntary recall with the
assistance of reports of corrections and removals as required by
section 519(g), or seizing a device that is adulterated under section
501 and/or misbranded under section 502. Thus, the provisions of the
final rule requiring direct marking certain reusable devices are issued
in aid of FDA's authority under all of these sections of the FD&C Act,
as well as under the Agency's broad authority to issue enforcement
regulations under section 701(a) and its specific authority to
implement UDI requirements to identify devices ``through distribution
and use'' of the device under section 519(f) (77 FR 69393 at 69395).
The only devices subject to direct marking in the final rule are
devices intended for more than one use and intended to be reprocessed
before each use. Though stand-alone software has been removed from the
direct marking provision of the final rule, the requirement that
packaged stand-alone software must bear a UDI on its label and device
packages as well as on a start-up screen or through a menu command has
been retained at Sec.  801.50(b). As discussed elsewhere in this
preamble, both of these categories of devices are intended to be used
long after they typically become separated from their label, making it
particularly important for the efficient enforcement of the provisions
outlined previously that these devices are directly marked with a UDI.

Y. Revision of Direct Marking Requirements--Proposed Sec.  801.50;
Sec.  801.45 of the Final Rule

    The proposed rule would have required a device that is intended to
be used more than once, and intended to be sterilized before each use,
to bear a permanent marking providing its UDI on the device itself.
(See proposed Sec.  801.50(a)(2).) This provision and the provisions in
proposed Sec.  801.50(b) through (f) have been moved to Sec.  801.45 of
the final rule, with certain modifications. All comments that pertain
to the requirements now included in Sec.  801.45 and to direct marking
requirements in general are discussed here.
    We broadened the scope of proposed Sec.  801.50(a)(2) to apply to
devices intended to be used more than once and intended to undergo any
form of reprocessing before each use; the proposed rule was limited to
devices intended to be reused and sterilized before each use. We made
this change because we see no reason for this

provision to be limited to sterilization; the same objectives served by
the proposed provision are applicable and will be served with respect
to all reprocessed devices. These devices are intended to be used for
months or years, sometimes many years. Because such a device is
intended to be reprocessed and reused, it will inevitably be separated
from its original label and device package. Direct marking is the only
way to ensure the adequate identification of such a device.
    A comment recommended that direct markings need to be ``as
permanent as the normal life expectancy'' of the device, and need to be
``capable of withstanding the normal usage and cleaning procedures''
specified for the device.
    FDA agrees that this is a reasonable approach, but we do not
believe it is appropriate to specify any particular approach in the
rule, because it would be difficult to define ``normal'' usage or
``normal'' cleaning procedures for all devices, and technological
advancements may change what constitutes normal usage and appropriate
cleaning procedures.
    A comment stated that direct marking is ``appropriate'' for single-
use sterilized devices, as well as for all devices intended for more
than one use.
    FDA disagrees that reprocessed single-use devices should be
directly marked because, by definition, the device is originally
intended only for a single-use. Direct marking is necessary to be able
to identify and locate devices subject to reprocessing in case of
problems with the reprocessing.
    A comment stated, ``to the extent practical, direct marking of
reusable devices should occur'' but also noted, that there ``may be
some products where size would prohibit direct marking with a UDI.''
Another comment suggested that direct marking may interfere with
sterilization of small devices.
    FDA has not been presented with any data that shows a correlation
between the size of a device marked with a UDI or similar mark and
ineffective sterilization or reprocessing. Accordingly, FDA is taking
no action in response to this comment. If a labeler can show that any
direct marking of a device would interfere with sterilization or
disinfection of the device, then the exception provided by Sec.
801.45(e)(1), ``Any type of direct marking would interfere with the
safety or effectiveness of the device,'' would apply.
    A comment suggested that direct marking be required for all devices
tracked under part 821, without exception.
    FDA disagrees. A device tracked under part 821 is subject to
controls that are specifically designed to take into account the
particular characteristics and uses of that device, and the tracking
requirements that apply to that device will ensure adequate
identification of the device throughout its distribution and use.
    A comment suggested that a reprocessor of a single-use device
should not be permitted to display any form of the original UDI.
    FDA disagrees. Section 830.60 requires that a relabeled device have
a new UDI; therefore it would not be permissible to display the
original UDI on the label or device package of the reprocessed device.
FDA does not believe it is appropriate to require physical modification
of a device in order to remove or obscure a UDI directly marked on the
device by the original manufacturer, as any such action could
compromise the physical characteristics of the device and might leave
imperfections that would make it more difficult to effectively
sterilize or disinfect the device.
    A comment suggested that the rule require direct marking with
``only one of the four production identifiers.''
    FDA disagrees. The full UDI is necessary for precise identification
of the device. For example, if a recall applies to only one lot or
batch, it would not help if the direct marking omitted that information
and instead provided only an expiration date that applies to several
lots--it would not be possible to distinguish only devices subject to
the recall from other devices that are not subject to the recall.
Accordingly, a device required to be directly marked under Sec.  801.45
must provide the full UDI, including all production identifiers that
appear on the device label.

Z. Devices That Must Be Directly Marked With a Unique Device
Identifier--Proposed Requirement for Submission of a Notice to FDA Upon
Determining That an Exception Applies--Proposed Sec.  801.50(g)

    FDA received several comments (approximately 13) concerning this
proposed requirement. These comments showed that the proposed
requirement was unclear and unlikely to be useful. For example, a
comment observed that FDA had not provided a way to inform the public
concerning exceptions to direct marking documented under Sec.
801.50(g). Some comments suggested FDA should acknowledge, and should
approve or reject, each notice of the use of an exception, and that
such notices should be called a ``request'' for exception, since an FDA
response would be required. Most comments appeared to be in agreement
with a comment that stated the requirement for submission of a notice
to FDA would be ``burdensome and impractical.''
    FDA agrees that this notice is not necessary. We do not require a
notice to FDA in other contexts when a decision is made that no action
is required; for example, FDA does not require a notice when a
manufacturer decides that a change made to a device does not require
submission of a 510(k) premarket notification. Accordingly, we have
withdrawn proposed Sec.  801.50(g), and a labeler will not have to
provide a notice to FDA when it decides an exception provided by Sec.
801.45(e) of the final rule applies. All such decisions must, however,
be documented in the design history file; see Sec.  801.45(f) of the
final rule.

AA. Special Requirements for Stand-Alone Software--Final Sec.  801.50

    The proposed rule included stand-alone software among the types of
devices that would have been subject to proposed Sec.  801.50,
requiring direct marking of certain devices; FDA moved the requirements
for direct marking to Sec.  801.45. Stand-alone software is not subject
to direct marking requirements in the final rule, but is subject to
requirements in new Sec.  801.50 of the final rule, which provides
special labeling requirements for stand-alone software.
    A comment asked how the requirement for AIDC would apply to cloud
software (software as a service), and the same question can be extended
to any software that is not distributed in packaged form, for example,
when downloaded from a Web site.
    Under Sec.  801.50(a) of the final rule, stand-alone software that
is not distributed in packaged form (e.g., when downloaded from a Web
site) is deemed to meet all UDI labeling requirements if the software
provides its UDI in a manner specified by Sec.  801.50(b), which
requires a plain-text statement of the UDI to be displayed whenever the
software is started, or a plain-text statement to be displayed through
a menu command (e.g., an ``About . . .'' command). When these
conditions are met, the use of AIDC is not required for stand-alone
software that is not distributed in packaged form. When distributed in
packaged form, Sec.  801.50(a) will not apply, and the label and device
package of stand-alone software must also include a UDI in plain-text
and through AIDC; see Sec.  801.40(a) of the final rule.

    A related comment suggested FDA should clarify how direct marking,
including production identifiers, applies to stand-alone software.
    As with AIDC, this will depend on whether or not the stand-alone
software is distributed in packaged form. If the stand-alone software
is not distributed in packaged form (e.g., when downloaded from a Web
site), it will be deemed to meet all UDI labeling requirements if the
software provides its UDI in a manner specified by Sec.  801.50(b). If
distributed in packaged form, if the label provides a lot or batch
number, a serial number, a manufacturing date, or an expiration date,
the UDI must include a production identifier segment that conveys such
information; see Sec.  801.40(b) of the final rule.
    Some commenters were concerned that because software updates occur
frequently, labelers would be faced with significant burdens of having
to provide new UDIs, and to change direct markings to reflect the new
UDI, with each update.
    FDA believes that this concern is resolved by Sec.  830.50 of the
final rule. Under Sec.  830.50, if a labeler makes a change to a
device, including a change to stand-alone software, a new UDI would be
required only if the change results in a new version or model. Section
830.50 is discussed in more detail later in this document.
    Some comments suggested that software that does not have a user
interface should be exempt from direct marking, and a similar comment
suggested that FDA should provide guidance concerning when software is
stand-alone software, and when it is a component of a device.
    FDA believes these comments concern software that is a component of
a device, rather than stand-alone software. The final rule does not
provide any special requirements for a device that contains software as
a component of the device, but does provide special labeling
requirements for stand-alone software (see Sec.  801.50). FDA has long
defined standalone medical software as medical software that is itself
a medical device and is not a component, part, or accessory of a
medical device.
    A comment stated, ``We disagree with FDA regarding the proposed
approach for UDI marking of stand-alone software. . . . FDA regulated
software already requires software version information to be provided,
which alone is sufficient of uniquely identifying software . . .
[S]tand-alone software could be exempted . . . without imposing undue
risk on public safety.'' This comment went on to recommend that ``if
FDA insists upon including stand-alone software under the UDI rule,''
FDA should provide requirements that ``recognize the unique
characteristics'' of software.
    FDA does not agree that stand-alone software should be excepted
from UDI labeling requirements. There are no FDA regulations that
require similar identification of stand-alone software and we know of
no ``special characteristics'' that would justify excepting stand-alone
software, and for the reasons discussed in section II.BB, ``Requests
for an Exception from or Alternative to a Unique Device Identifier
Requirement--Proposed Sec.  801.35; Sec.  801.55 of the Final Rule,''
FDA does agree that the final rule should provide exceptions that
``recognize the unique characteristics'' of software.
    We have revised Sec.  801.50 to focus on ``Special labeling
requirements for stand-alone software.'' Section 801.50 of the final
rule provides:
     An explanation of how stand-alone software can meet UDI
labeling requirements when it is not distributed in packaged form
(e.g., when it is downloaded from a labeler's Web site); such software
need comply only with Sec.  801.50(b) and is excepted from all other
UDI labeling requirements;
     A requirement for all stand-alone software to include a
means of displaying its UDI; stand-alone software that is distributed
in packaged form must display a UDI on its label, device package, and
on screen either upon startup or through a menu command;
     An explanation that stand-alone software that is
distributed in both packaged form and in a form that is not packaged
(e.g., when downloaded from a Web site) may be identified with the same
device identifier.
    FDA believes that Sec.  801.50 of the final rule provides
appropriate and reasonable requirements concerning the labeling of
stand-alone software, while taking into account the unique
characteristics of such devices.

BB. Request for an Exception From or Alternative to a Unique Device
Identifier Requirement--Proposed Sec.  801.35; Sec.  801.55 of the
Final Rule

    FDA received many comments (approximately 29) concerning this
section. When proposed, this section was titled, ``Request for an
exception from or alternative to the requirement for a device to bear a
unique device identifier.''
    Most of the comments on this section were concerned with various
aspects of the process outlined in the proposed rule, and sought more
clarity concerning the process, including timeframes, feedback,
decisions, and appeals. A typical comment stated, ``The procedure
should include: Upon receipt and approval of an exemption request, FDA
should notify the requester of the result, grant an exemption for the
entire PROCODE . . . where appropriate, and post all exemption requests
and results on an FDA managed Web site for public review. Additionally,
the burden of estimating the number of labelers and the number of
devices that would be affected by the exemption/alternative should be
deleted.'' Several comments suggested FDA provide categorical
exceptions to avoid the need to request an exception or alternative.
    FDA agrees that some categorical exceptions are useful, and the
final rule provides several; see Sec.  801.30 of the final rule and the
discussion of that section earlier in this document.
    A few comments suggested FDA should acknowledge the receipt of each
request, and other comments suggested FDA decisions should be made
public.
    FDA agrees. We intend to make each FDA decision available to the
public, along with the request or requests that prompted the decision.
    One comment suggested a request should be ``deemed'' accepted if
FDA does not provide a formal response within a specified timeframe.
    FDA disagrees. There may be many valid reasons why FDA might not be
able to respond to a particular request within the standard timeframe.
The final rule does not include such a provision.
    Two comments asked that a trade association be permitted to file a
request for an exception or alternative.
    FDA believes it is preferable for each request to be initiated by a
labeler, but we have no objection if a trade association submits its
views at the request of that labeler. The final rule has not been
modified to permit a trade association to initiate a request.
    FDA has made other important changes to this provision and the way
FDA will implement the provision. Later in this document, we explain
that FDA may, on its own initiative or upon the written request of the
labeler of a class III device or a device licensed under the PHS Act,
grant a 1-year extension of the compliance date applicable to Sec.
801.20 when FDA determines that the extension would be in the best
interest of the public health. Section 801.35(c) has been revised to
require all requests for an exception or alternative to be submitted
via email, and we have provided email addresses for requests concerning
products

regulated by the Center for Biologics Evaluation and Research (CBER),
and for all other products. Section 801.35(d) now makes clear that any
labeler may make use of an exception or alternative granted under this
section, provided that such use satisfies all safeguards or conditions
that are part of the exception or alternative. Section 801.35(e)
explains that FDA may initiate and grant an exception or alternative if
we determine that the exception or alternative is in the best interest
of the public health, and explains that any such exception or
alternative will remain in effect only so long as there remains a
public health need for the exception or alternative. Section 801.55(e)
provides that the Center Director may also rescind an exception or
alternative granted under this section if, after providing an
opportunity for an informal hearing, the Center Director determines
that the exception or alternative no longer satisfies the required
criteria or that any safeguard or condition required concerning the
device has not been met.

CC. Discontinuation of Legacy Identification Numbers Assigned to
Devices (National Drug Code and National Health-Related Item Code
Numbers)--Sec.  801.57

    FDA received several comments (approximately 12).
    Three comments recommended a transition period for depletion of
devices with legacy identifier that exist in the current supply chain.
    FDA believes these comments are adequately addressed by Sec.
801.30(a)(1) of the final rule, which provides a limited exception
period for existing inventories of finished devices; this is discussed
earlier in this document.
    Three comments urged FDA not to re-issue any NDC or NHRIC numbers
that were previously assigned, because use of a reassigned code could
result in confusion in patient records.
    Five comments urged FDA to permit labelers to continue using FDA
labeler codes that have been assigned to them. These comments explained
that many device manufacturers use the FDA labeler code as their GS1
Company Prefix, ``the basis for all GS1 product identification
numbers.'' (GS1 operates an existing, widely used system to identify
medical devices and other products, and has expressed interest in
applying to become an FDA-accrediting issuing agency.) These comments
went on to explain that if labelers are forced to discontinue use of
the FDA labeler code, they would have to assign new product identifiers
to their devices, create new labels and labeling, and that
``unnecessary cost and confusion'' would result.
    FDA agrees with these comments, and we have amended Sec.  801.57 to
include a new provision, paragraph (c), that will permit a labeler who
has been assigned a legacy FDA labeler code to continue to use that
labeler code under a system for the issuance of UDIs, provided that
such use is consistent with the framework of the issuing agency that
operates that system, and that the labeler submits, and obtains FDA
approval of, a request for continued use of the assigned labeler code.
    A few comments suggested FDA should permit continued use of legacy
identifiers, or suggested an alternative implementation schedule.
    FDA disagrees, as such changes would interfere with the objectives
served by Sec.  801.57. FDA has added 801.57(b) to clarify that ALL
medical devices, whether subject to UDI or not, may no longer use
legacy device identification systems after the applicable compliance
date.

DD. Requests for Clarification Concerning Whether Compliance With Any
Unique Device Identifier Requirement Will Require Submission of a
510(k) Premarket Notification or Premarket Approval Supplement

    A comment suggested the final rule ``should address when
[premarket] submissions to FDA will be required.'' This comment
provided two examples of areas where uncertainty exists, concerning
whether a submission will be required when direct marking of a device
is required, and whether a submission will be required when a label is
changed to include a UDI. Another comment stated that to provide MRI
compatibility information to the GUDID would be inconsistent with
existing FDA policies requiring the submission of a 510(k) premarket
notification or PMA supplement before labeling can include such
information, unless the GUDID provides an option to indicate that MRI
compatibility has not been evaluated.
    FDA agrees that these are important questions, and we are providing
the following guidance:
     The addition of a UDI to a device label or device package
is very unlikely to require the submission of a 510(k) premarket
notification or a PMA supplement. The addition of a UDI to the label of
a class III device should generally be reported in the next annual
report concerning the PMA of that device.
     The GUDID will provide some means to indicate that MRI
compatibility has not been evaluated. The final rule does not require
MRI-compatibility testing; it requires submission only of information
regarding MRI compatibility that the labeler already possesses.
     Although we believe it is possible that directly marking a
device might require a supplemental application in certain instances,
we cannot provide a definitive statement concerning whether a 510(k)
premarket notification or PMA supplement is required prior to
implementing direct marking of any particular device, because of the
wide variety of materials, manufacturing processes, intended uses,
types of required sterilization or other reprocessing, and many other
factors that vary from one device to another, even among devices of the
same general type. Therefore, we encourage labelers to contact the
relevant Center for Devices and Radiological Health (CDRH) or CBER
review division to determine whether direct marking could affect the
safety and effectiveness of the device in a way that triggers premarket
review requirements.

EE. Human Cells, Tissues, or Cellular or Tissue-Based Products That Are
Regulated as Devices--Sec. Sec.  801.3 and 801.20(a)(1)

    Several comments suggested FDA did not clearly explain how the UDI
rule would apply to HCT/Ps that are regulated as devices.
    FDA agrees. In particular, the final rule provides a definition for
HCT/P regulated as a device, and the definition unique device
identifier (UDI) has been modified to take into account the special
characteristics of HCT/Ps. (See Sec. Sec.  801.3, 803.3, 806.2, 810.2,
814.3, 820.3, 821.3, 822.3, and 830.3.) A particularly important change
is the inclusion of an additional production identifier that will
capture, for HCT/Ps regulated as devices only, the distinct
identification code required by Sec.  1271.290(c). Requiring this code
to be included in the production identifier when it appears on the
label of a device will ensure that the UDI system is consistent with
existing regulatory requirements, and existing identification and
tracking systems for HCT/Ps.

FF. Technical Standards Applicable to Part 830--Sec.  830.10

    FDA received four comments on this provision, which incorporates by
reference the technical standards essential to the UDI system.
    Two comments suggested FDA should require the UDI system to conform
to additional technical standards. A comment recommended FDA reduce the

allowable technical standards and formats to as few as possible, and
eliminate many options that were available under the proposed rule,
such as the freedom to choose among different issuing agencies, AIDC
technologies, options for production identifiers, and make other
choices concerning how best to comply with the requirements of the UDI
system.
    These same (or very similar) comments and issues are discussed
earlier in this document; see section II. S. ``Form of a Unique Device
Identifier--Technical Requirements--Proposed Sec.  801.45(a); Sec.
801.40(a) of the Final Rule.'' As explained earlier, FDA is not
accepting these suggestions.
    A comment suggested FDA remove the publication dates of the
standards listed in this section, so that a standard incorporated by
reference would automatically update to the current standard whenever a
change is made to that standard.
    FDA declines to accept this suggestion as doing so would
impermissibly allow the standards organizations to change regulatory
requirements without going through notice-and-comment rulemaking.

GG. Requirements for a Unique Device Identifier--Sec.  830.20

    FDA received six comments on this section.
    Three comments recommended that FDA designate a single issuing
agency, and require the UDI system to conform to additional standards.
    These comments repeat comments discussed earlier in this document;
see section II. S., ``Form of a Unique Device Identifier--Technical
Requirements--Proposed Sec.  801.45(a); Sec.  801.40(a) of the Final
Rule.'' FDA seeks to preserve existing flexibility concerning the
choice of issuing agency and notes requiring use of a single issuing
agency would disrupt current practices for many labelers that currently
use UDIs.
    As explained in section II. S., FDA does not agree with these
suggestions.
    One comment suggested that UDI ``codes'' should be standardized by
device type, and not be ``randomly assigned.'' A similar comment
stated, ``The database would be more useful if specific field lengths
were reserved for specific fields. Specifically we mean, reserve (for
example) the first 12 characters for the 'Device Identifier' and
characters 13-24 (for example) for the [Production Identifier].
Consider also dividing that number out into space for batch, date,
etc.''
    FDA does not agree with either of these comments. Under the system
provided by this rule, each FDA-accredited issuing agency will be
permitted to design and operate its device identification system in any
manner that conforms with the technical standards incorporated by
reference in part 830. FDA believes that a high degree of freedom and
flexibility is needed to ensure that the UDI system keeps pace with
technological change; we also believe that the system as a whole will
benefit from the options provided to labelers to choose among differing
systems and technologies. For those reasons, the final rule adopts the
language of the July 10, 2012, proposed rule without change.

HH. Use and Discontinuation of a Device Identifier--Sec.  830.40

    FDA received six comments on this provision.
    One comment stated that there should not be any consequences to the
labeler of a device if the accreditation of the issuing agency is
relinquished or revoked, and that the availability of GUDID data to
patients and providers needs to be ensured.
    FDA agrees. Section 830.40(d) addresses the concern regarding
accreditation of the issuing agency; a labeler may continue to use a
previously issued UDI on the label and packages of its device. FDA
intends to make the data submitted to the GUDID generally available on
our Web site indefinitely.
    A comment inquired as to whether a labeler who applies UDIs from
two issuing agencies to its device must report all data to the GUDID
twice, once for each UDI.
    FDA plans to design the GUDID data entry system so that such a
labeler will have to report GUDID data only once, and will be able to
add a UDI from an additional issuing agency to existing data concerning
a version or model.

II. Changes That Require Use of a New Device Identifier--Sec.  830.50

    When proposed, this section was titled, ``Changes that result in a
new version or model.'' FDA received many comments (approximately 56)
concerning these requirement.
    Although a few comments expressed support for certain requirements,
such as requiring a new UDI when adding a new device package, or when
changing to or from a sterile package, most comments viewed the
proposed requirements as ``too broad,'' or ``substantially and
unnecessarily overbroad'' because they would require new device
identifiers to be assigned ``when relatively minor changes are made to
the manufacture or specifications of a device.'' Many comments
suggested the need for clarification of various aspects of the proposed
language or suggested guidance would be required to understand the
proposed requirements. A comment recommended that the requirement for a
new UDI not be tied to changes that result in a new version or model,
because the device industry uses the terms version and model for many
different purposes, and ``it often makes sense to retain [existing
device] identifiers even after changes have been made. How these terms
are used . . . will vary by company. There is no standard . . . and no
consistency within the industry. . . .'' A similar comment stated,
``there are many situations in which a change to specifications,
performance, or composition should not require a new device identifier
. . . even if a supporting . . . 10(k) or PMA Amendment . . . were
required,'' and other comments added that requiring a new UDI whenever
any change is made to a device, even a change that would not be
noticeable by a user, would be overly burdensome. Other comments
suggested that in order to avoid confusion, the requirement for a new
UDI should be tied to a labeler's decision to use a new version or
model number.
    FDA agrees that the proposed language was too broad. We also agree
with the comments that suggested that in many instances the proposed
requirement to consider a changed device a new version or model would
conflict with common industry practice and that the rule should take
into account those common practices. The final rule simplifies the
requirement by assigning greater flexibility, and greater
responsibility, to the labeler. If the labeler makes a change to a
device that is required to bear a UDI on its label, and determines that
the change results in a new version or model, the labeler must assign a
new device identifier to that device and to all associated device
packages. FDA believes this approach provides adequate flexibility and
still ensures the adequate identification of devices through the UDI
system. We have also retitled Sec.  830.50 as, Changes that require use
of a new device identifier to reflect the change in emphasis.

JJ. FDA Accreditation of an Issuing Agency--Sec.  830.100

    FDA received many comments (approximately 41) on this provision.
    Some comments supported FDA's decision to leave the door open for
multiple issuing agencies to apply for accreditation, stating that
multiple issuing agencies would foster competition. Several other
comments

suggested FDA require conformance to additional standards, that FDA
should designate only one issuing agency, or should limit the number of
issuing agencies.
    These comments are the same as, or similar to, comments discussed
earlier in this document; see section II. S., ``Form of a Unique Device
Identifier--Technical Requirements--Proposed Sec.  801.45(a); Sec.
801.40(a) of the Final Rule.'' FDA does not agree with these comments,
for the reasons stated in the earlier discussion.
    In the proposed rule, we would have required an issuing agency to
be either a private nonprofit organization or a State agency, in order
to minimize potential conflicts of interest. We requested comment on
the question, ``Are there compelling reasons to permit a for-profit
organization to be accredited as an issuing agency?'' 77 FR 40736 at
40767 (Specific Question 26). Eight comments favored the
requirement in proposed Sec.  830.100(a) that only a nonprofit
organization can apply to become an issuing agency. Only two comments
recommended that we permit for-profit organizations to apply for
accreditation as an issuing agency, and another comment suggested we
allow any interested party to ``bid'' for the privilege of becoming an
issuing agency.
    We do not agree with the recommendation of the last commenter. We
believe an application process with transparent criteria is preferable
to a ``bidding'' process. We do not find the comments to be persuasive
on either side of the question of accrediting for-profit organizations
as issuing agencies.
    We note that the international standard addressing conflicts of
interest for accreditation bodies does not draw distinctions based on
profit or non-profit status. ISO/IEC 17011:2004, clause 4.3.4 (Ref. 16)
requires accreditation bodies to ensure that personnel and committees
that could influence the accreditation process act objectively and are
free from any undue commercial pressures that could compromise
impartiality. We believe the potential for conflicts, whether or not
related to an applicant's for-profit status, are best addressed through
FDA's oversight of the application process and accrediting body
criteria such as required conformance to standards rather than
establishing a blanket prohibition. In the proposed rule, we would have
limited accreditation to organizations that are non-profit in part ``to
minimize potential conflicts.'' In the final rule, we are allowing any
private organization, for-profit or non-profit, to be accredited as an
issuing agency, as long as there is protection against conflicts of
interest. We have added protections against conflicts of interest to
Sec. Sec.  830.100(b) (Accreditation criteria), 830.110(a) (Application
for initial accreditation), and 830.130 (Suspension or revocation of
the accreditation of an issuing agency). See 78 FR 45782 (July 29,
2013) (Proposed rule for accreditation of foreign food safety
auditors). We also specifically prohibit an issuing agency from
engaging in anticompetitive activities in restraint of trade.
    A few comments suggested that FDA serve as an issuing agency, or as
the only issuing agency.
    FDA does not agree and notes the suggested approach could require
labelers that have voluntarily labeled their devices with UDIs to
assign new UDIs to comply with the rule. We believe the UDI system will
be best served if qualified private organizations that have relevant
experience operate the day-to-day technical aspects of the UDI system.
In addition, we have removed the provision that would have allowed a
State agency to serve as an issuing agency. Although FDA may act as an
issuing agency if it is necessary or appropriate for us to do so (see
Sec.  830.200 of the final rule), we believe that FDA's expertise and
resources are best applied to other functions.
    One comment suggested that FDA address the constitutionality of the
requirement that companies contract with third-party non-government
companies or agencies that may impose their own requirements on a
manufacturer that may exceed FDA's regulatory authority, such as fees
for service. This comment stated that, constitutionally, the government
may not assign a government function to non-governmental entities. This
comment appears to be directed at the requirement at Sec.  830.20 that
UDIs be issued under a system operated by FDA or an FDA-accredited
issuing agency and conform to certain international standards regarding
issuing agencies.
    While FDA recognizes the constitutional limitations regarding the
delegation of functions to private entities, FDA has not impermissibly
delegated any governmental authority to issuing agencies or any other
entities in this rule. Rather, the role that this rule creates for
issuing agencies to serve in the unique device identification system is
one that is ministerial and completely subordinate to FDA's ultimate
authority over the compliance of unique device identifiers with the
FD&C Act, these regulations, and the international standards
incorporated by reference in the regulations. (See, e.g., Sunshine
Anthracite Coal Co. v. Adkins, 310 U.S. 381, 399 (1940) (upholding
Congressional delegation of function to private entity because
``members of the [private entity] functioned subordinately to the
[public agency],'' which had ``authority and surveillance'' over the
private entity); Pittston Co. v. United States, 368 F.3d 385, 395 (4th
Cir. 2004) (``Congress may employ private entities for ministerial or
advisory roles, but it may not give these entities governmental power
over others.'' (citing Sunshine Anthracite, 310 U.S. at 399, United
States v. Frame, 885 F.2d 1119, 1129 (3d Cir. 1989), cert. denied, 493
U.S. 1094 (1990))). Issuing agencies will be performing the ministerial
function of issuing unique labeler codes for device identifiers and
operating a system of identifier creation and maintenance focused on
ensuring the uniqueness of alphanumeric codes, as the entities
currently in existence already do. No UDI provides any advantage over
any other UDI. FDA retains a high degree of control over the issuing
agencies through the requirements providing that issuing agencies must
be accredited by FDA, that FDA may suspend or revoke of an issuing
agency's accreditation, and that FDA may act as issuing agency if
necessary or appropriate. (See subparts C and D of part 830 of the
final rule.)
    One comment suggested that FDA adopt far more detailed criteria for
the accreditation of issuing agencies (other comments stated the
criteria are appropriate) and that FDA should assign the task of
accrediting issuing agencies to the private sector by designating a
``board of providers . . . to run the selection process'' in a manner
that would ensure the needs of providers are met.
    FDA disagrees with these suggestions. We have specified the
criteria we believe are appropriate for our review of applications for
accreditation as an issuing agency, and we are not persuaded that the
UDI system needs, or would benefit from, more detailed accreditation
criteria. As discussed in the response to the previous comment, FDA
oversight of issuing agencies through accreditation is important from a
legal standpoint, and we will not consider transferring this
responsibility to a nongovernmental body.
    Having considered the comments submitted concerning Sec.  830.100,
the final rule adopts the language proposed in our July 10, 2012,
proposed rule without any change.

KK. Information Required for Unique Device Identification--Sec.
830.310

    FDA received many comments (approximately 125) concerning these
requirements.
    Several comments we received requested a greater level of detail
than we believe appropriate for this rule; nonetheless, many of these
comments we expect to address in guidance on various aspects of the UDI
system. Several comments asked for information or guidance concerning
how to submit data to, and how to locate data in, the GUDID, or
inquired about various technical aspects of the GUDID, such as security
processes or whether or how the GUDID will be linked to other data
systems.
    Our general approach has been to regard a comment that did not
suggest the need for a change to the regulatory language of this
section as being a request for guidance. We will consider all such
comments as we develop guidance concerning the final rule and the
GUDID, and we plan to provide information concerning functions of the
GUDID.
    A comment asked whether the GUDID will accommodate reporting data
concerning a device that has been assigned device identifiers under
more than one issuing agency's system to assign UDIs.
    The GUDID is being designed to accept data from multiple systems
when necessary.
    A comment suggested that each labeler should be allowed the
flexibility to determine ``what information will be reflected in the .
. . GUDID.'' Some comments expressed concern that the publicly
available GUDID may reveal proprietary information such as the number
of devices manufactured.
    FDA disagrees. Labelers are required to report only the type of
production identifiers that appear on the label of the device to the
GUDID, which would not reveal the number of devices manufactured. FDA
does not believe any of the information required to be reported to the
GUDID, most of which appears on the label of the device, would
constitute trade secret or confidential commercial information.
    A comment suggested the GUDID should not include company contact
data, because it is typically a corporate officer whose contact
information is not public. To serve as its point of contact with FDA on
GUDID matters under Sec.  830.32(a), the labeler of a device might
designate a senior officer whose contact information is not otherwise
publicly known. Unlike the other GUDID data that will help identify
devices through distribution and use by having it included in the
public GUDID, FDA intends to use the contact person data submitted
under Sec.  830.310(a)(2) solely for internal purposes in managing the
GUDID. The public side of the GUDID database will not otherwise contain
any individual contact information, except for optional customer-
service information if the submitting company chooses to provide
individual contact information for that purpose. FDA plans to address
in guidance the privacy aspects of how contact-person information will
be handled, as well as other issues associated with the public
availability of GUDID information.
    A comment suggested that the GUDID data requirement should be
harmonized with what is collected for other device repositories
globally.
    Although FDA appreciates the goal of global harmonization and has
structured this regulation to further those goals in many ways, FDA
does not fully agree with this comment. We have designed the GUDID to
meet the needs of the UDI system established by this rule, and we have
carefully specified the data we believe are essential to the success of
the system. The sponsors of other systems may have other objectives and
may make different decisions.

LL. Information Required for Unique Device Identification--Information
Concerning Each Version or Model of a Device--Sec.  830.310(b)

    FDA received many comments concerning the specific information
required under Sec.  830.310(b). Two comments voiced support for
inclusion of GMDN codes in the GUDID.
    Most of the comments concerned the requirement to submit the GMDN
code of a device to the GUDID, and the majority of those comments
opposed collection of GMDN codes for the following reasons: At the time
the proposed rule was published, the GMDN Agency required a license fee
to be paid to obtain GMDN codes; comments expressed concern regarding
whether the GMDN system has codes for HCT/Ps regulated as devices; and
comments expressed a preference that additional nomenclature systems be
utilized, such as the Universal Medical Device Nomenclature System
(UMDNS) and the United Nations Standard Products and Services Code
(UNSPSC). One comment suggested FDA allow GMDN codes to be voluntarily
submitted as ancillary data under Sec.  830.340.
    FDA believes the bases for most objections to the requirement
concerning GMDN codes have been eliminated. In the preamble to our July
10, 2012, proposed rule, FDA stated that the GMDN code would not be
required unless GMDN codes were made freely available. The GMDN Agency
has agreed to provide free access to GMDN nomenclature within the
context of the GUDID data submission process. A labeler who reports
data to the GUDID will be able to enter a GMDN code if the labeler
knows it, or may use a module integrated in the GUDID reporting system
to search for and select the correct GMDN term, including for HCT/Ps
regulated as devices. Because of these actions and FDA's belief that
the use of GMDN nomenclature will add precision and consistency to the
identification of medical devices, FDA is including the requirement for
submission of GMDN codes in the final rule.
    One comment argued that requiring submission of GMDN information is
``anti-competitive'' and would allow the GMDN Agency to skirt the
Sherman Antitrust Act.
    FDA disagrees. Permitting the submission of device terms from more
than one nomenclature system would undermine the purposes of this
provision: Consistent terminology for the identification of devices.
FDA does not believe reliance upon the GMDN classification system for
this program will foreclose the use of alternative classification
systems in other contexts. Accordingly, competition among
classification systems should not be adversely affected. We also note
that FDA as an agency of the Federal Government, FDA is immune from
antitrust liability. See United States Postal Service v. Flamingo
Indus., Ltd., 540 U.S. 736, 748 (2004); Name. Space, Inc. v. Network
Solutions, Inc., 202 F.3d 573, 581 (2d Cir. 2000) (National Science
Foundation has ``absolute immunity from the antitrust laws'').
    A comment suggested that the requirement for submission of the
proprietary, trade, or brand name of the device as it appears on the
label of the device be expanded to permit the submission of ``other
names, if applicable.''
    FDA does not understand how ``other names'' would contribute
towards improved identification of devices, and we have not added
``other names'' to the GUDID's requirements.
    Approximately 16 comments recommended adding MRI compatibility
information to the GUDID, while 2 comments specifically opposed
inclusion of MRI compatibility information, and another 8 comments
expressed general opposition to including any additional data element
beyond those proposed in the July 19, 2012, proposed rule.

    FDA agrees with the comments that suggest FDA should require
submission of MRI compatibility information to the GUDID to the extent
it is otherwise available. Because identification of devices that are
MRI compatible and ones that are not can be critical to the safety of
patients, we have included a requirement for MRI compatibility
information at Sec.  830.310(b)(8) of the final rule. See second bullet
point of section II.DD of this document. This final rule does not alter
the criteria for when MRI compatibility must be determined.
    One comment opposed inclusion of information in the GUDID
concerning latex and whether the device is labeled as sterile, because
GUDID is an ``incomplete surrogate for appropriate and complete
instructions for use'' and these elements might discourage providers
from reading the full labeling.
    FDA believes this concern is misplaced, as we do not intend, and do
not expect, the GUDID to be used in lieu of instructions for use
provided on a device label or patient package insert. We have retained
the requirements.
    Several comments recommended significant expansion of GUDID
reporting requirements to include additional data, including an
indication that a device is either a prescription device or an over-
the-counter device; the Healthcare Common Procedural Coding System
Level II code; indications that a device is mercury free, Di(2-
ethylhexyl)phthalate free, and thimerosal free; information on recalls,
storage and handling conditions, hazardous warnings, radioactive
isotopes data, and whether there is a Material Safety Data Sheets
notice; an indication that hazardous materials and radioactive isotopes
are present; ``clinical attributes of the devices for meaningful post-
market surveillance and research''; previously used NDC/NHRIC codes,
the Systematized Nomenclature of Medicine Clinical Terms (SNOMED) CT
identifier, and the Logical Observation Identifiers Names and Codes
(LOINC) code for tests; all package-insert information submitted in
structured product labeling (SPL) format or as a stable link; storage
and handling conditions; and more. Most of these proposals appeared
only in a single comment.
    At this time, FDA is not convinced that adding any of these
proposed requirements would contribute towards the objectives of the
UDI system in a way that outweighs the costs of including them in the
system, and therefore we have not included any of these proposals in
the final rule.

MM. Enforcement Authority

    One comment stated that the proposed rule does not articulate the
enforcement actions for noncompliance and asked FDA to detail its
enforcement authority as it relates to the UDI system.
    As explained in the legal authority section of the proposed rule,
failure or refusal to furnish any material or information required by
or under section 519 of the FD&C Act causes a device to be misbranded
under section 502(t)(2) and is a prohibited act under section
301(q)(1)(B) of the FD&C Act (21 U.S.C. 331(q)(1)(B)). Potential
enforcement actions for violations of UDI requirements include seizure,
injunction, and civil and criminal penalties.

NN. Questions and Comments Suggesting the Need for Additional Guidance

    We received many comments that requested guidance or suggested a
need for guidance on various aspects of the rule. We also received
comments asking how the rule would apply to specific medical devices.
    FDA will develop guidance to help labelers understand and apply the
requirements of this final rule as necessary, and comments requesting
guidance will be carefully considered to ensure our guidance will
address their principal concerns. We plan to provide one or more draft
guidance documents for comment in the next year.

OO. Requests for Additional Opportunity for Comment Prior To Issuing a
Final Rule

    A few comments requested FDA take extraordinary steps to provide
additional opportunities for comment before issuing a final rule. One
comment suggested FDA should hold a public workshop to get feedback
specifically concerning convenience kits.
    FDA does not agree that any additional opportunities for comments
are necessary. The July 10, 2012, proposed rule provided a liberal
comment period ending November 7, 2012, and the November 19, 2012,
amended proposed rule provided an additional comment period ending
December 19, 2012. Furthermore, section 519(f) of the FD&C Act, as
amended by FDASIA, requires FDA to ``finalize the proposed regulations
not later than 6 months after the close of the comment period . . . .''
and FDA has no authority to extend that deadline. For changes making
the final rule less burdensome for convenience kits, see section II.L
(Exception for a Device Packaged Within the Immediate Container of a
Combination Product or Convenience Kit).

III. Legal Authority for the Final Rule

    Section 226 of the Food and Drug Administration Amendments Act
(Pub. L. 110-85) (2007), amended the FD&C Act by adding a new section
519(f). This section authorizes FDA to issue regulations establishing a
unique device identification system for medical devices. In addition,
section 510(e) of the FD&C Act authorizes FDA to issue regulations to
``prescribe a uniform system for identification of devices'' and to
require persons to ``list such devices in accordance with such
system.'' Therefore, FDA is issuing the provisions of this rule
establishing a unique device identification system under sections
510(e), 519(f), and 701(a) of the FD&C Act (which provides FDA the
authority to issue regulations for the efficient enforcement of the
FD&C Act).
    Devices for which there has been a failure or refusal to furnish
any material or information required by or under section 519 of the
FD&C Act respecting the device are misbranded under section 502(t)(2)
of the FD&C Act. The failure or refusal to furnish any material or
information required by or under section 519 of the FD&C Act is a
prohibited act under section 301(q)(1)(B) of the FD&C Act.
    Section 701(a) of the FD&C Act gives FDA the authority to issue
regulations for the efficient enforcement of the FD&C Act. By requiring
a UDI to appear on the label of devices, and by establishing the GUDID,
the rule is designed to improve the accuracy and precision of adverse
event reporting, as required by section 519(a) and (b) of the FD&C Act,
which will enable FDA to more quickly and precisely identify device
problems, such as safety and/or effectiveness concerns. Once a problem
is identified, whether through improved reporting or otherwise, the
presence of the UDI on the device label, packaging, in certain cases
directly marked on the device itself, and in the GUDID will enable FDA
to more efficiently and effectively respond, and protect the public
health by addressing the problem using one or more of the regulatory
tools that Congress has provided for this purpose, such as notification
or mandatory recall under section 518 of the FD&C Act, tracking under
section 519(e) of the FD&C Act, ensuring the adequacy of a voluntary
recall with the assistance of reports of corrections and removals as
required by section 519(g) of the FD&C Act, or seizing a device that is
adulterated under section 501 of the FD&C Act and/or misbranded under
section 502 of the FD&C Act. Thus,

these provisions of the rule are issued under the authority of these
sections in addition to the broad authority of section 519(f) of the
FD&C Act.
    The information required to be submitted to the GUDID under Sec.
830.310 is necessary for UDIs to adequately identify devices through
distribution and use, as required by section 519(f) of the FD&C Act.
Collection of this information is further authorized by section 510(j)
of the FD&C Act, which requires listing information to be accompanied
by, at minimum, the label, package insert, and a representative
sampling of any other labeling for the device (see section
510(j)(1)(B)(ii)). Most of the information required to be submitted to
the GUDID is information that appears on the device label or in the
package insert, and is included in the information that is required to
be submitted to FDA by section 510(j).
    The provisions of the rule that would require UDIs to be included
in various FDA records and reports to FDA, allow the use of UDIs to
identify devices subject to reports of corrections and removals and
records of corrections of removals that are not required to be reported
to FDA, and require reporting of UDIs in periodic reports for class III
devices, are issued under the authority of sections 519 and 701(a) of
the FD&C Act.
    The provisions of the rule that would amend the Quality System
Regulation by requiring examination of the accuracy of the UDI as part
of the scope of the labeling inspection, that the device history record
include any UDI or UPC, that complaint records include any UDI or UPC,
and that the service report include any UDI or UPC, are issued under
sections 520(f) (21 U.S.C. 360j(f)) and 701(a) of the FD&C Act.
    The provisions of the rule that would require the inclusion of UDIs
on reports regarding tracked devices is authorized by sections 519(e)
and 701(a) of the FD&C Act.
    The provision of the rule that would require that postmarket
surveillance plans submitted to FDA include the device identifier of
the devices involved is issued under sections 522 (21 U.S.C. 360l), and
701(a) of the FD&C Act.
    The changes in compliance dates for devices that are implantable,
life-saving, and life sustaining, are under the changes to section
519(f) of the FD&C Act made by section 614 of FDASIA.
    The provision in the rule requiring dates on device labels intended
to be brought to the attention of the user to appear in a particular
format is issued under the authority of sections 502(a), 502(c), and
701(a) of the FD&C Act. The requirement for a uniform date format will
ensure dates on device labels intended to be brought to the attention
of the user are not misleading, and to the extent these dates are
required to appear on the label, ensure that they are likely to be
understood by the ordinary individual under customary conditions of
use.

IV. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct Agencies to assess all
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety, and other advantages; distributive impacts; and
equity). The Agency finds that this final rule is an economically
significant regulatory action under Executive Order 12866.
    The Regulatory Flexibility Act requires Agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. FDA has examined the impacts of this rule as
required by the Regulatory Flexibility Act. FDA finds that the
potential impact of the final rule on some small entities may be
significant. This Regulatory Impact Analysis and other sections of the
preamble to the final rule constitute FDA's regulatory flexibility
analysis.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that Agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $141 million, using the most current (2012) Implicit
Price Deflator for the Gross Domestic Product. The estimated costs of
this final rule will result in a 1-year expenditure that exceeds this
amount.
    This final rule requires the label and packages of medical devices
to bear a UDI and provides for alternative placement and exceptions for
certain devices. In addition, this final rule requires certain devices
to be directly marked with a UDI, with exceptions. Medical device
records throughout the required device recordkeeping and reporting
systems will need to be modified to include the UDI. Under this final
rule, FDA will establish the GUDID, a public database containing
information about devices labeled with a UDI. The final rule requires
labelers of medical devices to submit information concerning each
device to the GUDID. In addition, the final rule establishes
accreditation requirements for agencies that may operate a system for
the issuance of UDIs and establishes the conditions for when FDA might
act as an issuing agency.

A. Summary of Impacts

1. Summary of Costs
    The full discussion of the Final Regulatory Impact Analysis, Final
Regulatory Flexibility Analysis, and Unfunded Mandates Reform Act
Analysis (Ref. 17) is available in docket FDA-2011-N-0090 and at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/ucm309815.htm.
    The detailed data for this cost analysis were developed by Eastern
Research Group, Inc. (ERG) under contract to FDA and are presented in
the full report ``Unique Device Identification (UDI) for Medical
Devices: Economic Analysis of the Final Rule,'' 2013 (cited in Ref.
17). The final ERG report updates the 2012 ERG cost analysis used to
support the FDA's Preliminary Regulatory Impact Analysis of the
proposed rule. The Preliminary Regulatory Impact Analysis and the 2012
ERG report are available at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/ucm309815.htm.
    Table 2 of this document presents for each affected sector a
summary of the estimated present value and the annualized domestic
costs of this final rule over 10 years using discount rates of 7
percent and 3 percent. Over 10 years, the estimated present value of
the total domestic costs is $642.2 million using a 7 percent discount
rate and $737.7 million using a 3 percent rate, and the annualized
costs are $85.7 million using a 7 percent discount rate and $84.1
million using a 3 percent discount rate.

          Table 2--Summary of the Estimated Domestic Regulatory Costs of the Final Rule (2012 dollars)
----------------------------------------------------------------------------------------------------------------
                                                   Total present value of  cost    Total annualized  costs over
                                                     over 10 years ($ million)         10 years ($ million)
                Affected sectors                 ---------------------------------------------------------------
                                                     3 Percent       7 Percent       3 Percent       7 Percent
----------------------------------------------------------------------------------------------------------------
Domestic Labelers \1\...........................          $713.2          $620.4           $81.2           $82.6
Issuing Agencies................................             1.4             1.3             0.2             0.2
FDA.............................................            23.1            20.5             2.7             2.9
                                                 ---------------------------------------------------------------
    Total Domestic Cost of the Final Rule.......           737.7           642.2            84.1            85.7
----------------------------------------------------------------------------------------------------------------
\1\ Present value and annualized costs calculated at the beginning of the period.

2. Costs to Domestic Labelers
    The majority of the costs of this final rule will be incurred by
labelers of medical devices. Labelers include manufacturers,
reprocessors, specification developers, repackagers and relabelers that
cause a label to be applied to a medical device. The estimated present
value of the costs for domestic labelers over 10 years is $620.4
million at a 7 percent discount rate and $713.2 million at 3 percent.
Over 10 years, the annualized costs for domestic labelers are $82.6
million at a 7 percent discount rate and $81.2 million at 3 percent.
The largest components of one-time costs include planning and
administration and the costs to integrate the UDI into existing
information systems; to install, test, and validate barcode printing
software; and to train employees. Other significant components of one-
time costs include costs to redesign labels of devices to incorporate
the barcode and date format, and to purchase and install equipment
needed to print and verify the UDI on labels. In addition, labelers
will incur one-time costs for recordkeeping and reporting requirements,
and the direct marking of certain devices.
    The largest annual cost components include labor, operating, and
maintenance associated with equipment for printing operations, and
labor related to software maintenance and training needed to maintain
the UDI information system.
3. Costs To Issuing Agencies
    Three existing organizations now perform functions similar to those
of an issuing agency under the final rule; the estimated present value
of costs over 10 years for these three to apply for FDA accreditation
and comply with the final reporting requirements is $1.3 million at a 7
percent discount rate and $1.4 million at 3 percent. The annualized
costs over 10 years are be $0.2 million at both 7 percent and 3 percent
discount rates. There may be other organizations that might apply to
FDA to become an issuing agency. In such cases, the estimated
application preparation, legal, and reporting costs apply to other
organizations.
4. Costs to FDA To Establish and Maintain the GUDID
    The estimated present value over 10 years of the costs to FDA to
establish and maintain the GUDID is $20.5 million at a 7 percent
discount rate and $23.1 million at 3 percent. The annualized costs over
10 years are $2.9 million at 7 percent and $2.7 million at 3 percent.
5. Costs to Foreign Labelers
    Although we excluded foreign costs from our initial regulatory
analysis, in our final regulatory impact analysis we include an
estimate of the costs to foreign labelers. From Agency device
registration and listing data we find that foreign labelers exporting
devices to the United States are located in about 90 countries. Because
there can be substantial variability in the labor and capital costs
labelers face in different countries, we divide foreign labelers into
four groups, apply different assumptions to each group, and estimate
costs for each group. Over 10 years, the annualized present value for
all foreign labelers equals about $75 million with both a 7 and 3
percent discount rate. The present value of the total costs of the
final rule for foreign labelers equals about $561 million with a 7
percent discount rate.
6. Uncertainty
    We computed uncertainty ranges based on the percentage relationship
between the lower and upper bounds surrounding the central estimate of
the costs to domestic labelers. The lower bound is about 57 percent
lower and the upper bound about 43 percent higher than the central
estimate. Applying a similar range of uncertainty to the total costs of
the final rule to domestic labelers, issuing agencies, and FDA, over 10
years the total annualized domestic costs range from $48.8 million to
$122.5 million at 7 percent and $47.9 million to $120.2 million at 3
percent.
7. Alternatives
    For the final rule, we compare two alternatives to the final rule.
We estimate costs for a full coverage UDI requirement that does not
allow reduced requirements for class I devices and for devices that FDA
has by regulation exempted from the GMP requirements. The second
alternative varies the content of the UDI and requires only the
establishment and the device identifier to be included in the barcode
across all device classes.
    Over 10 years at 7 percent, the annualized present value of the
highest cost alternative is about $108.0 million. This alternative
applies the UDI requirements to class I, II, and III devices, as well
as unclassified devices, unless excepted by Sec.  801.30(a)(3) through
(11). Under the lower cost alternative labelers do not incur costs in
certain categories such as purchasing and installing printing equipment
and software. The annualized present value of this alternative is about
$20 million.

B. Summary of Regulatory Flexibility Analysis

    FDA conducted a regulatory flexibility analysis of the impact of
the final rule on small entities. About 96 percent of domestic labelers
are small firms according to Small Business Administration size
standards. The average annualized costs of compliance for domestic
labelers as a percentage of annual receipts exceed 1 percent for about
32 firms with fewer than 19 employees that label multiple-use devices
subject to the direct marking requirements. Without direct marking, the
impact on small firms does not exceed 1 percent of average annual
receipts.

C. Summary of Benefits

    The public health benefits from the UDI are related to reductions
in medical device-related patient injuries and deaths. The final rule
is expected to

improve medical device event reporting by providing a standardized,
reliable and unique identifier with which to report a problem device.
With more reliable identification of devices associated with an adverse
medical event, FDA would be able to improve postmarket surveillance of
medical devices and detect problem devices more rapidly. FDA expects
that more accurate and prompt identification of problems would lead to
a reduced incidence of adverse events. Public health safety alerts, for
example, could be more accurate and timely. Similarly, FDA expects that
recall actions could more effectively target a problem device. We
expect that the increased accuracy of adverse medical device reporting
and improved recalls would reduce the total number of adverse medical
device events, although we are unable to quantify that reduction.
    In addition, a standardized UDI will contribute to future potential
public health benefits from initiatives associated with the increased
use of automated systems in healthcare. Most of these benefits,
however, require complementary developments and innovations in the
private and public sectors, and investments by the healthcare industry;
such benefits are beyond the scope of this rule. The ROCIS (Regulatory
Information Service Center and Office of Information and Regulatory
Affairs Combined Information System) accounting information is shown in
table 3 of this document.

                                             Table 3--Economic Data: Costs and Benefits Accounting Statement
                                                                     [2012 dollars]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Units
                                                                                ---------------------------------------------------------------
               Category                    Primary estimate         Low          High                    Discount      Period
                                                                  estimate     estimate       Year         rate       covered             Notes
                                                                                dollars     (percent)     (years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
    Annualized.......................  .......................  ...........  ...........  ...........            7  ...........  .......................
    Monetized $millions/year.........  .......................  ...........  ...........  ...........            3  ...........  .......................
    Annualized.......................  .......................  ...........  ...........  ...........            7  ...........  .......................
    Quantified.......................  .......................  ...........  ...........  ...........            3
--------------------------------------------------------------------------------------------------------------------------------------------------------
    Qualitative......................  More accurate and prompt identification of device
                                        related adverse events should lead to more rapid
                                          action to reduce the incidence of the adverse
                                        events and to more effectively target and manage
                                                     medical device recalls.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs:
    Annualized.......................  $85.7..................        $48.8       $122.5         2012            7     10 years  Costs to foreign
                                                                                labelers are not
                                                                                included.
    Monetized $millions/year.........  84.1...................         47.9        120.2         2012            3     10 years  .......................
    Annualized.......................  .......................  ...........  ...........  ...........            7  ...........
    Quantified.......................  .......................  ...........  ...........  ...........            3  ...........
    Qualitative......................  .......................  ...........  ...........  ...........  ...........  ...........
Transfers:
    Federal..........................  .......................  ...........  ...........  ...........            7  ...........  .......................
    Annualized Monetized $millions/    .......................  ...........  ...........  ...........            3  ...........  .......................
     year.
--------------------------------------------------------------------------------------------------------------------------------------------------------
From/To                                From
                                       To                                                 ...........
--------------------------------------------------------------------------------------------------------------------------------------------------------
    Other............................  .......................  ...........  ...........  ...........            7  ...........  .......................
    Annualized Monetized $millions/    .......................  ...........  ...........  ...........            3  ...........  .......................
     year.
--------------------------------------------------------------------------------------------------------------------------------------------------------
From/To                                From:
                                       To:                                                ...........
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects:
State, Local or Tribal Government: No effect                                                                                .......................
Small Business: The final rule may have a significant economic impact on a substantial number of small entities that label       .......................
 medical devices.
Wages: No effect                                                                                .......................
Growth: No effect                                                                                .......................
--------------------------------------------------------------------------------------------------------------------------------------------------------

V. Information Collection Requirements

    This final rule contains information collection requirements (OMB
control 0910-0720) that are subject to review by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501-3520) (the PRA). The title, description, and respondent
description of the information collection provisions are shown in the
following paragraphs with an estimate of the reporting, recordkeeping,
and third-party disclosure burden. Included in the estimate is the time
for reviewing instructions, searching existing data sources, gathering
and maintaining the data needed, and completing and reviewing each
collection of information. It should be noted that the burden
assumptions for some of these requirements reflect one possible manner
of compliance, and have only

been identified for the purposes of estimating the PRA burden.
    Title: Unique Device Identification System
    Description: In accordance with the collection of information
entitled ``Unique Device Identification System (UDI),'' medical device
labelers, unless excepted, are required to design and use medical
device labels and device packages that bear a UDI, present dates on
labels in a particular format, and submit data concerning each version
or model of a device to the GUDID no later than the date the label of
the device must bear a UDI. Once a device becomes subject to UDI
requirements, respondents will be required to update the information
reported whenever the information changes. Respondents required to
submit data to the Agency under certain other information collections
are required to include the UDI for the device that is the subject of
such information collection.
    Section 801.18 requires that whenever a labeler of a medical device
includes an expiration date, a date of manufacture, or any other date
intended to be brought to the attention of the user of the device, the
labeler must present the date on the label in a format that meets the
requirements of this section. Section 801.20 requires every medical
device label and package to bear a UDI. Under Sec.  801.35, any labeler
of a device that is not required to bear a UDI on its label may include
a UDI on the label of that device and utilize the GUDID. Under Sec.
801.45, any device that has to be labeled with a UDI also has to bear a
permanent marking providing the UDI on the device itself if the device
is intended for more than one use and intended to be reprocessed before
each use. Section 801.50 requires stand-alone software to comply with
specific labeling requirements that identify the software. Section
801.55 authorizes additional, case-by-case, labeling exceptions and
alternatives to standard UDI labeling requirements. If a labeler
relabels or modifies a label of a device that is required to bear a
UDI, under Sec.  830.60 it has to keep a record showing the
relationship of the original device identifier to the new device
identifier.
    Section 830.110 requires an applicant seeking initial FDA
accreditation as a UDI-issuing agency to furnish to FDA an application
containing certain information, materials, and supporting
documentation. Under Sec.  830.120, an FDA-accredited issuing agency is
required to disclose information concerning its system for the
assignment of UDIs; maintain a list of labelers that use its system for
the assignment of UDIs and provide FDA a copy of such list; and upon
request, provide FDA with information concerning a labeler that is
employing the issuing agency's system for assignment of UDIs. Sections
830.310 and 830.320 require the labeler to provide certain information
to the GUDID concerning the labeler and each version or model of a
device required to be labeled with a UDI, unless the labeler obtains a
waiver. Section 830.360 requires each labeler to retain records showing
all UDIs used to identify devices that must be labeled with a UDI and
the particular version or model associated with each device identifier,
until 3 years after it ceases to market a version or model of a device.
    To require the use of UDIs to identify devices referenced in other
information collections, the rule makes conforming amendments to part
803 (Medical Device Reporting), part 806 (Medical Devices; Reports of
Corrections and Removals), part 814 (Premarket Approval of Medical
Devices), part 820 (Quality System Regulation), part 821 (Medical
Device Tracking Requirements), and part 822 (Postmarket Surveillance).
    Description of Respondents: The recordkeeping, reporting, and
third-party disclosure requirements referenced in this document are
imposed on any person who causes a label to be applied to a device, or
who causes the label to be modified, with the intent that the device
will be commercially distributed without any subsequent replacement or
modification of the label. In most instances, the labeler would be the
device manufacturer, but other types of labelers include a
specification developer, a single-use device reprocessor, a convenience
kit assembler, a repackager, or a relabeler. Respondents may also
include any private organization that applies for accreditation by FDA
as an issuing agency.
    Requirements Reflected in the Burden Estimates: FDA has identified
the following requirements as having burdens that must be accounted for
under the PRA; the burdens associated with these requirements are
summarized in the tables that follow:
    1. Sec.  801.18 Format of dates provided on a medical device label.
    2. Sec.  801.20 Label to bear a unique device identifier.
    3. Sec.  801.35 Voluntary labeling of a device with a unique device
identifier.
    4. Sec.  801.45 Devices that must be directly marked with a unique
device identifier.
    5. Sec.  801.50 Labeling requirements for stand-alone software.
    6. Sec.  801.55 Request for an exception from or alternative to a
unique device identifier.
    7. Sec.  830.60 Relabeling of a device that is required to bear a
unique device identifier.
    8. Sec.  830.110 Application for accreditation as an issuing
agency.
    9. Sec.  830.120 Responsibilities of an FDA-accredited issuing
agency.
    10. Sec.  830.310 Information required for unique device
identification.
    11. Sec.  830.320 Submission of unique device identification
information.
    12. Sec.  830.360 Records to be maintained by the labeler.
    13. Conforming amendments to Part 803--Medical Device Reporting
    14. Conforming amendments to Part 806--Medical Devices; Reports of
Corrections and Removals.
    15. Conforming amendments to Part 814--Premarket Approval of
Medical Devices
    16. Conforming amendments to Part 820--Quality System Regulation
    17. Conforming amendments to Part 821--Medical Device Tracking
Requirements
    18. Conforming amendments to Part 822--Postmarket Surveillance

                                    Table 4--First Year Estimated Burdens \1\
----------------------------------------------------------------------------------------------------------------
                                   Number of       Number of
                                  respondents    responses per   Total annual    Average burden     Total hours
                                      \2\       respondent \3\   responses \4\  per response \5\        \6\
----------------------------------------------------------------------------------------------------------------
Reporting.....................             372             102          37,938  0.070 (4                   2,662
                                                                                minutes).
Recordkeeping.................             366             371         135,652  0.081 (5                  11,055
                                                                                minutes).
Third-Party Disclosure (UDI)..             359           5,304       1,905,303  0.012 (1 minute)          23,790
Third-Party Disclosure (Date             6,199             102         632,298  1 hour..........         632,298
 Format).
----------------------------------------------------------------------------------------------------------------
\1\ Table 4 shows the burden to labelers affected in the first year.

\2\ Maximum number of respondents for any regulatory requirement within each category. Individual regulatory
  requirements within the category may involve fewer respondents.
\3\ Maximum number of responses for any regulatory requirement within each category. Individual regulatory
  requirements within the category may involve fewer responses.
\4\ Maximum total annual responses for any regulatory requirement within each category. Individual regulatory
  requirements within the category may involve fewer total annual responses.
\5\ Rounded to three decimals. Total hours reflect a more precise, non-rounded average burden per response. An
  approximate (non-rounded) conversion to minutes is shown in parentheses.
\6\ Total hours are based on a more precise burden per response than the rounded value shown in these tables.

                                    Table 5--Ongoing Estimated Annual Burdens
----------------------------------------------------------------------------------------------------------------
                                   Number of       Number of
                                  respondents    responses per   Total annual    Average burden     Total hours
                                      \1\       respondent \2\   responses \3\  per response \4\        \5\
----------------------------------------------------------------------------------------------------------------
Reporting.....................           6,199              51         316,149  0.023 (1 minute)           7,289
Recordkeeping.................           5,987              51         305,337  0.989 (59                302,121
                                                                                minutes).
Third-Party Disclosure........           5,987              51         305,337  0.885 (53                270,143
                                                                                minutes).
----------------------------------------------------------------------------------------------------------------
\1\ Maximum number of respondents for any regulatory requirement within each category. Individual regulatory
  requirements within the category may involve fewer respondents.
\2\ Maximum number of responses for any regulatory requirement within each category. Individual regulatory
  requirements within the category may involve fewer responses.
\3\ Maximum total annual responses for any regulatory requirement within each category. Individual regulatory
  requirements within the category may involve fewer total annual responses.
\4\ Rounded to three decimals. Total hours reflect a more precise, non-rounded average burden per response. An
  approximate (non-rounded) conversion to minutes is shown in parentheses.
\5\ Total hours are based on a more precise burden per response than the rounded value shown in these tables.

    The information collection provisions in this final rule have been
submitted to OMB for review as required by section 3507(d) of the PRA.
    Before the effective date of this final rule, FDA will publish a
notice in the Federal Register announcing OMB's decision to approve,
modify, or disapprove the information collection provisions in this
final rule. An agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays
a currently valid OMB control number.

VI. Environmental Impact

    FDA has determined under 21 CFR 25.30(h) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

VII. Effective Dates

    A. Effective Dates. This rule is effective on December 23, 2013,
except the following provisions are effective October 24, 2013--
     Sec.  801.55--Request for an exception from or alternative
to a unique device identifier requirement.
     Sec.  830.10--Incorporation by reference.
     Sec. Sec.  830.100, 830.110, 830.120, and 830.130--
Provisions regarding FDA accreditation of issuing agencies.
    B. Compliance Dates. FDA is establishing compliance dates for the
following provisions of this final rule in order to provide labelers,
FDA, and the health care community adequate time to build and test the
systems and infrastructure required to implement the final rule's
requirements, and to spread the costs and burdens of implementation
over a period of years. FDA believes this approach will help ensure the
efficient and effective implementation of the final rule.
    Compliance dates for: Sec.  801.18--Format of dates provided on a
medical device label; Sec.  801.20--Label to bear a unique device
identifier; Sec.  801.50--Special labeling requirements for stand-alone
software; and Sec.  830.300--Devices subject to device identification
data submission requirements.
    FDA is establishing compliance dates for Sec. Sec.  801.18, 801.20,
801.50, and 830.300 as follows for any device that its labeler puts in
commercial distribution after the applicable date indicated below:
    1. For a class III medical device or a device licensed under the
Public Health Service Act, September 24, 2014. FDA may, on its own
initiative, or upon a written request made under Sec.  801.55 by the
labeler of device, grant a 1-year extension of this compliance date
when FDA determines that the extension would be in the best interest of
the public health. A written request for such an extension must:
    a. Identify the device or devices that would be subject to the
extension;
    b. Provide, if known, the number of labelers and the number of
devices that would be affected if we grant the extension;
    c. Explain why such an extension would be in the best interest of
the public health;
    d. Provide other requested information that the Center Director
needs to clarify the scope and effects of the requested extension; and
    e. Be submitted no later than June 23, 2014.
    2. For an implantable, life-supporting, or life-sustaining device
that is not covered by paragraph 1., September 24, 2015.
    3. For a class II medical device that is not covered by paragraph
2., September 24, 2016.
    4. For a class I medical device that is not covered by paragraph
2., September 24, 2018.
    5. For a convenience kit that is not classified into class I, II,
or III, the earliest compliance date that would apply to any device in
the convenience kit if distributed separately from the convenience kit.
    6. For a device that is not classified into class I, II, or III,
September 24, 2018.
    Compliance dates for Sec.  801.45--Devices that must be directly
marked with a unique device identifier. FDA is establishing compliance
dates for Sec.  801.45 as follows--
    1. For a device that is a life-supporting or life-sustaining
device, September 24, 2015.
    2. For any other device, 2 years after the compliance date that
applies to the requirements of Sec. Sec.  801.18, 801.20, 801.50, and
830.300.

         Table 6--Summary of Compliance Dates for the Final Rule
------------------------------------------------------------------------
           Compliance date                        Requirement
------------------------------------------------------------------------
1 year after publication of the final  The labels and packages of class
 rule (September 24, 2014).             III medical devices and devices
                                        licensed under the Public Health
                                        Service Act (PHS Act) must bear
                                        a UDI. Sec.   801.20.
                                       Dates on the labels of these
                                        devices must be formatted as
                                        required by Sec.   801.18. Data
                                        for these devices must be
                                        submitted to the GUDID database.
                                        Sec.   830.300.
                                       A 1-year extension of this
                                        compliance date may be requested
                                        under Sec.   801.55; such a
                                        request must be submitted no
                                        later than June 23, 2014.
                                       Class III stand-alone software
                                        must provide its UDI as required
                                        by Sec.   801.50(b).
2 years after publication of the       The labels and packages of
 final rule (September 24, 2015 ).      implantable, life-supporting,
                                        and life-sustaining devices must
                                        bear a UDI. Sec.   801.20.
                                       Dates on the labels of these
                                        devices must be formatted as
                                        required by Sec.   801.18.
                                       A device that is a life-
                                        supporting or life-sustaining
                                        device that is required to be
                                        labeled with a UDI must a bear
                                        UDI as a permanent marking on
                                        the device itself if the device
                                        is intended to be used more than
                                        once and intended to be
                                        reprocessed before each use.
                                        Sec.   801.45.
                                       Stand-alone software that is a
                                        life-supporting or life-
                                        sustaining device must provide
                                        its UDI as required by Sec.
                                        801.50(b).
                                       Data for implantable, life-
                                        supporting, and life-sustaining
                                        devices that are required to be
                                        labeled with a UDI must be
                                        submitted to the GUDID database.
                                        Sec.   830.300.
3 years after publication of the       Class III devices required to be
 final rule (September 24, 2016).       labeled with a UDI must bear a
                                        UDI as a permanent marking on
                                        the device itself if the device
                                        is a device intended to be used
                                        more than once and intended to
                                        be reprocessed before each use.
                                        Sec.   801.45.
                                       The labels and packages of class
                                        II medical devices must bear a
                                        UDI. Sec.   801.20.
                                       Dates on the labels of these
                                        devices must be formatted as
                                        required by Sec.   801.18.
                                       Class II stand-alone software
                                        must provide its UDI as required
                                        by Sec.   801.50(b).
                                       Data for class II devices that
                                        are required to be labeled with
                                        a UDI must be submitted to the
                                        GUDID database. Sec.   830.300.
5 years after publication of the       A class II device that is
 final rule (September 24, 2018).       required to be labeled with a
                                        UDI must bear a UDI as a
                                        permanent marking on the device
                                        itself if the device is a device
                                        intended to be used more than
                                        once and intended to be
                                        reprocessed before each use.
                                        Sec.   801.45.
                                       The labels and packages of class
                                        I medical devices and devices
                                        that have not been classified
                                        into class I, class II, or class
                                        III must bear a UDI. Sec.
                                        801.20.
                                       Dates on the labels of all
                                        devices, including devices that
                                        have been excepted from UDI
                                        labeling requirements, must be
                                        formatted as required by Sec.
                                        801.18.
                                       Data for class I devices and
                                        devices that have not been
                                        classified into class I, class
                                        II, or class III that are
                                        required to be labeled with a
                                        UDI must be submitted to the
                                        GUDID database. Sec.   830.300.
                                       Class I stand-alone software must
                                        provide its UDI as required by
                                        Sec.   801.50(b).
7 years after publication of the       Class I devices, and devices that
 final rule (September 24, 2020).       have not been classified into
                                        class I, class II, or class III
                                        that are required to be labeled
                                        with a UDI, must a bear UDI as a
                                        permanent marking on the device
                                        itself if the device is a device
                                        intended to be used more than
                                        once and intended to be
                                        reprocessed before each use.
                                        Sec.   801.45.
------------------------------------------------------------------------
Compliance dates for all other provisions of the final rule. Except for
 the provisions listed in this table, FDA requires full compliance with
 the final rule as of the effective date that applies to the provision..
------------------------------------------------------------------------

VIII. Federalism

    FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. FDA has determined that the rule,
if finalized, would not contain policies that would have substantial
direct effects on the States, on the relationship between the National
Government and the States, or on the distribution of power and
responsibilities among the various levels of government. Accordingly,
the Agency concludes that the rule does not contain policies that have
federalism implications as defined in the Executive order and,
consequently, a federalism summary impact statement is not required.

IX. References

    The following references have been placed on display in the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday,
and are available electronically at http://www.regulations.gov. (FDA
has verified the Web site addresses, but FDA is not responsible for any
subsequent changes to the Web sites after this document publishes in
the Federal Register.)

1. See referenced ISO standards and ISO Technical Committees listed
at http://www.iso.org/iso/standards_development/technical_committees/list_of_iso_technical_committees/iso_technical_committee.htm?commid=45332.
2. For information about UPC and other barcodes and GS1, go to
http://www.gs1us.org/standards/barcodes.
3. ``The Health Industry Bar Code (HIBC) Supplier Labeling
Standard,'' ANSI/HIBC 2.3-2009, Health Industry Business
Communications Council, 2009, at http://www.hibcc.org/publication/view/supplier-labeling-standard/.
4. ``Automatic Identification of Medical Devices,'' ECRI Institute,
August 17, 2005.
5. See record and public comments related to the October 25, 2006
public meeting, referenced at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/.
6. See ERG's 2006 report at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/ucm054169.htm.
7. See discussion of HL7 implementation of SPL model for medical
product information at http://wiki.hl7.org/index.php?title=Medical_Product_Information_(SPLr5).
8. Letter from Michael D. Maves, M.D., MBA, Executive Vice President
and CEO, American Medical Association, regarding confusion caused by
inconsistencies in the presentation of expiration dates on medical
devices, August 27, 2008.

9. List of class I devices, by product code, that FDA has by
regulation exempted from the GMP requirements of 21 CFR Part 820,
Quality Systems Regulation, FDA, April 2012.
10. Unique Device Identification System; Proposed Rule: Preliminary
Regulatory Impact Analysis; Initial Regulatory Flexibility Analysis;
Unfunded Mandates Reform Act Analysis: available at http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/UCM310427.pdf.
11. Supporting Statement for Unique Device Identification (UDI)
System, 21 CFR Parts 16, 801, 803, 806, 810, 814, 820, 821, 822, and
830, OMB Control Number 0910-0720.
12. List of medical devices, by product code, that FDA classifies as
implantable, life-saving, and life-sustaining devices for purposes
of section 614 of FDASIA amending section 519(f) of the FD&C Act,
September 2013.
13. Addendum to the Preliminary Regulatory Impact Analysis of the
Proposed Rule to Require a Unique Device Identification System,
Docket No. FDA-2011-N-0090.
14. ``Healthcare GTIN Allocation Rules, GS1 Global Healthcare User
Group,'' ] 5.1.6., GS1, June 2013 (Issue 8).
15. See: International Standards ISO/IEC 15459-2:2006(E):
Information Technology--Unique Identifiers--Part 2: Registration
Procedures, ] 3.1.1, and ISO/IEC 15459-3:2006(E): Information
Technology--Unique Identifiers--Part 3: Common Rules for Unique
Identifiers, ] 4, nn. 2 and 3, listed at http://www.iso.org/iso/standards_development/technical_committees/list_of_iso_technical_committees/iso_technical_committee.htm?commid=45332.
16. See International Standard ISO/IEC 17077:2004(E) Conformity
assessment--General requirements for accreditation bodies
accrediting conformity assessment bodies, listed at http://www.iso.org/iso/standards_development/technical_committees/list_of_iso_technical_committees/iso_technical_committee.htm?commid=45332.
17. Unique Device Identification System; Final Rule: Final
Regulatory Impact Analysis, Final Regulatory Flexibility Analysis,
and Unfunded Mandates Reform Act Analysis; available at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/ucm309815.htm.

List of Subjects

21 CFR Part 16

    Administrative practice and procedure.

21 CFR Part 801

    Labeling, Medical devices, Reporting and recordkeeping
requirements.

21 CFR Parts 803, 806, and 821

    Imports, Medical devices, Reporting and recordkeeping requirements.

21 CFR Part 810

    Administrative practice and procedure, Medical devices, Reporting
and recordkeeping requirements.

21 CFR Part 814

    Administrative practice and procedure, Confidential business
information, Medical devices, Medical research, Reporting and
recordkeeping requirements.

21 CFR Parts 820 and 822

    Medical devices, Reporting and recordkeeping requirements.

21 CFR Part 830

    Administrative practice and procedure, Incorporation by reference,
Labeling, Medical devices, Reporting and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 321 et seq., as amended) and under authority delegated to the
Commissioner of Food and Drugs, chapter I of title 21 is amended to
read as follows:

PART 16--REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION

0
1. The authority citation for 21 CFR part 16 continues to read as
follows:

    Authority: 15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-394,
467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201-262, 263b, 364.

0
2. Amend Sec.  16.1(b)(2) by numerically adding an entry for ``Sec.
830.130'' to read as follows:

Sec.  16.1  Scope.

* * * * *
    (b) * * *
    (2) * * *
    Sec.  830.130, relating to suspension or revocation of the
accreditation of an issuing agency.
* * * * *

PART 801--LABELING

0
3. The authority citation for 21 CFR part 801 continues to read as
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 360i, 360j, 371, 374.

Subpart A--[Amended]

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4a. Add new Sec.  801.3 to read as follows:

Sec.  801.3  Definitions.

    As used in this part:
    Automatic identification and data capture (AIDC) means any
technology that conveys the unique device identifier or the device
identifier of a device in a form that can be entered into an electronic
patient record or other computer system via an automated process.
    Center Director means the Director of the Center for Devices and
Radiological Health or the Director of the Center for Biologics
Evaluation and Research, depending on which Center has been assigned
lead responsibility for the device.
    Combination product has the meaning set forth in Sec.  3.2(e) of
this chapter.
    Convenience kit means two or more different medical devices
packaged together for the convenience of the user.
    Device package means a package that contains a fixed quantity of a
particular version or model of a device.
    Expiration date means the date by which the label of a device
states the device must or should be used.
    FDA, we, or us means the Food and Drug Administration.
    Finished device means any device or accessory to any device that is
suitable for use or capable of functioning.
    Global Unique Device Identification Database (GUDID) means the
database that serves as a repository of information to facilitate the
identification of medical devices through their distribution and use.
    Human cells, tissues, or cellular or tissue-based product (HCT/P)
regulated as a device means an HCT/P as defined in Sec.  1271.3(d) of
this chapter that does not meet the criteria in Sec.  1271.10(a) and
that is also regulated as a device.
    Implantable device means a device that is intended to be placed in
a surgically or naturally formed cavity of the human body. A device is
regarded as an implantable device for the purpose of this part only if
it is intended to remain implanted continuously for a period of 30 days
or more, unless the Commissioner of Food and Drugs determines otherwise
in order to protect human health.
    Label has the meaning set forth in section 201(k) of the Federal
Food, Drug, and Cosmetic Act.
    Labeler means:
    (1) Any person who causes a label to be applied to a device with
the intent that the device will be commercially distributed without any
intended subsequent replacement or modification of the label; and
    (2) Any person who causes the label of a device to be replaced or
modified with the intent that the device will be commercially
distributed without any subsequent replacement or modification of the
label, except that the addition of the name of, and contact information
for, a person who distributes the device, without making any other
changes to the label, is not a modification for the

purposes of determining whether a person is a labeler.
    Lot or batch means one finished device or more that consist of a
single type, model, class, size, composition, or software version that
are manufactured under essentially the same conditions and that are
intended to have uniform characteristics and quality within specified
limits.
    Shipping container means a container used during the shipment or
transportation of devices, and whose contents may vary from one
shipment to another.
    Specification means any requirement with which a device must
conform.
    Unique device identifier (UDI) means an identifier that adequately
identifies a device through its distribution and use by meeting the
requirements of Sec.  830.20 of this chapter. A unique device
identifier is composed of:
    (1) A device identifier--a mandatory, fixed portion of a UDI that
identifies the specific version or model of a device and the labeler of
that device; and
    (2) A production identifier--a conditional, variable portion of a
UDI that identifies one or more of the following when included on the
label of the device:
    (i) The lot or batch within which a device was manufactured;
    (ii) The serial number of a specific device;
    (iii) The expiration date of a specific device;
    (iv) The date a specific device was manufactured;
    (v) For an HCT/P regulated as a device, the distinct identification
code required by Sec.  1271.290(c) of this chapter.
    Universal product code (UPC) means the product identifier used to
identify an item sold at retail in the United States.
    Version or model means all devices that have specifications,
performance, size, and composition, within limits set by the labeler.

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4b. Add new Sec.  801.18 to subpart A to read as follows:

Sec.  801.18  Format of dates provided on a medical device label.

    (a) In general. Whenever the label of a medical device includes a
printed expiration date, date of manufacture, or any other date
intended to be brought to the attention of the user of the device, the
date must be presented in the following format: The year, using four
digits; followed by the month, using two digits; followed by the day,
using two digits; each separated by hyphens. For example, January 2,
2014, must be presented as 2014-01-02.
    (b) Exceptions. (1) A combination product that properly bears a
National Drug Code (NDC) number is not subject to the requirements of
paragraph (a) of this section.
    (2) If the device is an electronic product to which a standard is
applicable under subchapter J of this chapter, Radiological Health, the
date of manufacture shall be presented as required by Sec.
1010.3(a)(2)(ii) of this chapter.

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5a. Effective October 24, 2013, add subpart B consisting of Sec.
801.55 to read as follows:

Subpart B--Labeling Requirements for Unique Device Identification

Sec.  801.55  Request for an exception from or alternative to a unique
device identifier requirement.

    (a) A labeler may submit a request for an exception from or
alternative to the requirement of Sec.  801.20 or any other requirement
of this subpart for a specified device or a specified type of device. A
written request for an exception or alternative must:
    (1) Identify the device or devices that would be subject to the
exception or alternative;
    (2) Identify the provisions of this subpart that are the subject of
the request for an exception or alternative;
    (3) If requesting an exception, explain why you believe the
requirements of this subpart are not technologically feasible;
    (4) If requesting an alternative, describe the alternative and
explain why it would provide for more accurate, precise, or rapid
device identification than the requirements of this subpart or how the
alternative would better ensure the safety or effectiveness of the
device that would be subject to the alternative;
    (5) Provide, if known, the number of labelers and the number of
devices that would be affected if we grant the requested exception or
alternative; and
    (6) Provide other requested information that the Center Director
needs to clarify the scope and effects of the requested exception or
alternative.
    (b) A written request for an exception or alternative must be
submitted by sending it:
    (1) If the device is regulated by the Center for Biologics
Evaluation and Research (CBER), by email to:
<EMAIL_ADDRESS>or by correspondence to: Office of
Communication, Outreach and Development (HFM-40), Center for Biologics
Evaluation and Research, Food and Drug Administration, 1401 Rockville
Pike, Suite 200N, Rockville, MD 20852-1448.
    (2) In all other cases, by email to<EMAIL_ADDRESS>or by
correspondence to: UDI Regulatory Policy Support, Center for Devices
and Radiological Health, Food and Drug Administration, Bldg. 66, Rm.
3303, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002.
    (c) The Center Director may grant an exception or alternative,
either in response to a request or on his or her own initiative, if the
Center Director determines that an exception is appropriate because the
requirements of this subpart are not technologically feasible, or that
an alternative would provide for more accurate, precise, or rapid
device identification than the requirements of this subpart or would
better ensure the safety or effectiveness of the device that would be
subject to the alternative. If we grant an exception or alternative, we
may include any safeguards or conditions deemed appropriate to ensure
the adequate identification of the device through its distribution and
use. Any labeler may make use of an exception or alternative granted
under this section, provided that such use satisfies all safeguards or
conditions that are part of the exception or alternative.
    (d) FDA may initiate and grant an exception or alternative if we
determine that the exception or alternative is in the best interest of
the public health. Any such exception or alternative will remain in
effect only so long as there remains a public health need for the
exception or alternative.
    (e) The Center Director may rescind an exception or alternative
granted under this section if, after providing an opportunity for an
informal hearing as defined in section 201(x) of the Federal Food,
Drug, and Cosmetic Act and under part 16 of this chapter, the Center
Director determines that the exception or alternative no longer
satisfies the criteria described in this paragraph (e) or that any
safeguard or condition required under this paragraph (e) has not been
met.

0
5b. Effective December 23, 2013, add Sec. Sec.  801.20, 801.30, 801.35,
801.40, 801.45, and 801.50 to subpart B to read as follows:

Sec.
801.20 Label to bear a unique device identifier.
801.30 General exceptions from the requirement for the label of a
device to bear a unique device identifier.
801.35 Voluntary labeling of a device with a unique device
identifier.
801.40 Form of a unique device identifier.
801.45 Devices that must be directly marked with a unique device
identifier.
801.50 Labeling requirements for stand-alone software.

Sec.  801.20  Label to bear a unique device identifier.

    (a) In general. (1) The label of every medical device shall bear a
unique device identifier (UDI) that meets the requirements of this
subpart and part 830 of this chapter.
    (2) Every device package shall bear a UDI that meets the
requirements of this subpart and part 830 of this chapter.
    (b) Exceptions. Exceptions to the general rule of paragraph (a) of
this section are provided by Sec. Sec.  801.30, 801.45, and
801.128(f)(2), and Sec.  801.55 provides a means to request an
exception or alternative not provided by those provisions.

Sec.  801.30  General exceptions from the requirement for the label of
a device to bear a unique device identifier.

    (a) In general. The following types of devices are excepted from
the requirement of Sec.  801.20; a device within one or more of the
following exceptions is not required to bear a unique device identifier
(UDI):
    (1) A finished device manufactured and labeled prior to the
compliance date established by FDA for Sec.  801.20 regarding the
device. This exception expires with regard to a particular device 3
years after the compliance date established by FDA for the device.
    (2) A class I device that FDA has by regulation exempted from the
good manufacturing practice requirements of part 820 of this chapter,
exclusive of any continuing requirement for recordkeeping under
Sec. Sec.  820.180 and 820.198.
    (3) Individual single-use devices, all of a single version or
model, that are distributed together in a single device package,
intended to be stored in that device package until removed for use, and
which are not intended for individual commercial distribution. This
exception is not available for any implantable device. The device
package containing these individual devices is not excepted from the
requirement of Sec.  801.20, and must bear a UDI.
    (4) A device used solely for research, teaching, or chemical
analysis, and not intended for any clinical use.
    (5) A custom device within the meaning of Sec.  812.3(b) of this
chapter.
    (6) An investigational device within the meaning of part 812 of
this chapter.
    (7) A veterinary medical device not intended for use in the
diagnosis of disease or other conditions in man, in the cure,
mitigation, treatment, or prevention of disease in man, or intended to
affect the structure or any function of the body of man.
    (8) A device intended for export from the United States.
    (9) A device held by the Strategic National Stockpile and granted
an exception or alternative under Sec.  801.128(f)(2).
    (10) A device for which FDA has established a performance standard
under section 514(b) of the Federal Food, Drug, and Cosmetic Act and
has provided therein an exception from the requirement of Sec.  801.20,
or for which FDA has recognized all or part of a performance standard
under section 514(c) of the Federal Food, Drug, and Cosmetic Act and
has included an exception from the requirement of Sec.  801.20 within
the scope of that recognition.
    (11) A device packaged within the immediate container of a
combination product or convenience kit, provided that the label of the
combination product or convenience kit bears a UDI.
    (b) National Drug Code (NDC) Numbers. If a combination product
properly bears an NDC number on its label--
    (1) The combination product is not subject to the requirements of
Sec.  801.20.
    (2) A device constituent of such a combination product whose
components are physically, chemically, or otherwise combined or mixed
and produced as a single entity as described by Sec.  3.2(e)(1) of this
chapter is not subject to the requirements of Sec.  801.20.
    (3) Each device constituent of such a combination product, other
than one described by Sec.  3.2(e)(1) of this chapter, must bear a UDI
on its label unless paragraph (a)(11) of this section applies.
    (c) Exception for shipping containers. This rule does not require a
UDI to be placed on any shipping container.
    (d) The UDI of a class I device is not required to include a
production identifier.

Sec.  801.35  Voluntary labeling of a device with a unique device
identifier.

    (a) The labeler of a device that is not required to bear a unique
device identifier (UDI) may voluntarily comply with Sec.  801.20. If a
labeler voluntarily includes a UDI for a device, the labeler may
voluntarily provide information concerning the device under subpart E
of part 830 of this chapter.
    (b) A device may bear both a Universal Product Code (UPC) and a UDI
on its label and packages.

Sec.  801.40  Form of a unique device identifier.

    (a) Every unique device identifier (UDI) must meet the technical
requirements of Sec.  830.20 of this chapter. The UDI must be presented
in two forms:
    (1) Easily readable plain-text, and
    (2) Automatic identification and data capture (AIDC) technology.
    (b) The UDI must include a device identifier segment. Whenever a
device label includes a lot or batch number, a serial number, a
manufacturing date, an expiration date, or for a human cell, tissue, or
cellular or tissue-based product (HCT/P) regulated as a device, a