[Federal Register Volume 78, Number 185 (Tuesday, September 24, 2013)]
[Rules and Regulations]
[Pages 58785-58828]
[FR Doc No: 2013-23059]

Vol. 78

Tuesday,

No. 185

September 24, 2013

Part V

Department of Health and Human Service

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 Food and Drug Administration

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21 CFR Parts 16, 801, 803, et al.

Unique Device Identification System; Final Rule

Federal Register / Vol. 78 , No. 185 / Tuesday, September 24, 2013 /
Rules and Regulations

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 16, 801, 803, 806, 810, 814, 820, 821, 822, and 830

[Docket No. FDA-2011-N-0090]
RIN 0910-AG31

Unique Device Identification System

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is issuing a final rule
to establish a system to adequately identify devices through
distribution and use. This rule requires the label of medical devices
to include a unique device identifier (UDI), except where the rule
provides for an exception or alternative placement. The labeler must
submit product information concerning devices to FDA's Global Unique
Device Identification Database (GUDID), unless subject to an exception
or alternative. The system established by this rule requires the label
and device package of each medical device to include a UDI and requires
that each UDI be provided in a plain-text version and in a form that
uses automatic identification and data capture (AIDC) technology. The
UDI will be required to be directly marked on the device itself if the
device is intended to be used more than once and intended to be
reprocessed before each use.

DATES: This rule is effective December 23, 2013, except Sec. Sec.
801.55, 830.10, 830.100, 830.110, 830.120, and 830.130 are effective
October 24, 2013. The incorporation by reference of Sec.  830.20 listed
in the rule is approved by the Director of the Office of the Federal
Register as of December 23, 2013. The incorporation by reference of
Sec. Sec.  830.10 and 830.100 listed in the rule is approved by the
Director of the Office of the Federal Register as of October 24, 2013.
Certain provisions have later compliance dates as discussed in section
VII. B. ``Compliance Dates.''

FOR FURTHER INFORMATION CONTACT: Jay Crowley, 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,<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Executive Summary

Purpose of the Regulatory Action

    This final rule will substantially reduce existing obstacles to the
adequate identification of medical devices used in the United States.
By making it possible to rapidly and definitively identify a device and
key attributes that affect its safe and effective use, the rule will
reduce medical errors that result from misidentification of a device or
confusion concerning its appropriate use. The identification system
established under this rule will lead to more accurate reporting of
adverse events by making it easier to identify the device prior to
submitting a report. It will allow FDA, health care providers, and
industry to more rapidly extract useful information from adverse event
reports, pinpoint the particular device at issue and thereby gain a
better understanding of the underlying problems, and take appropriate,
better-focused, corrective action. The rule will also require dates on
medical device labels to conform to a standard format to ensure those
dates are unambiguous and clearly understood by device users.
    The rule fulfills a statutory requirement of section 519(f) of the
Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360i(f))
that directs FDA to issue regulations establishing a unique device
identification system for medical devices. The rule also meets
statutory requirements added by section 614 of the Food and Drug
Administration Safety and Innovation Act (FDASIA), including a deadline
for publication of this final rule and requirements concerning when the
rule must apply to devices that are implantable, life-supporting, or
life-sustaining.
    Under the UDI system established by this rule, the health care
community and the public will be able to identify a device through a
UDI that will appear on the label and package of a device. The UDI will
function as the key that can be used to obtain critical information
from the GUDID about the medical product. The GUDID will include only
information that is important to the identification of devices, and
will not include any information that would identify a patient. UDIs
will appear in both plain-text format and a format that can be read by
a bar code scanner or some other AIDC technology. If a device is
intended to be used more than once, and intended to be reprocessed
before each use, it must also be directly marked with a UDI, allowing
accurate identification even when the device is no longer accompanied
by its label or package.
    By establishing a system for the adequate identification of medical
devices through distribution and use, the rule will serve several
important public health objectives:
    Reduce Medical Errors. The presence of a UDI that is linked to
device information in the GUDID will facilitate rapid and accurate
identification of a device, thereby removing a cause of confusion that
can lead to inappropriate use of a device. Using a device's UDI, you
will be able to use the GUDID to positively identify the device and
obtain important descriptive information, preventing confusion with any
similar device which might lead to misuse of the device. Health care
providers will no longer have to access multiple, inconsistent, and
potentially incomplete sources in an attempt to identify a device, its
key attributes, and a designated source for additional information.
    Simplify the Integration of Device Use Information Into Data
Systems. UDIs, particularly when provided through AIDC technology, will
allow rapid and accurate data acquisition, recording, and retrieval.
For example, the use of UDIs in computerized physician order entry
systems will help ensure that the intended device will be used in the
treatment of a patient, rather than some similar device that may not
fully meet the needs of the health care professional who ordered the
use of the device.
    Provide for More Rapid Identification of Medical Devices With
Adverse Events. An essential prerequisite to resolving adverse events
is the timely and precise identification of the particular device or
devices that may have a connection with an adverse event. The inclusion
of UDIs in adverse event reports would lead to greater accuracy in
reporting by eliminating uncertainty concerning the identity of the
device that is the subject of a report.
    Provide for More Rapid Development of Solutions to Reported
Problems. The rule requires the inclusion of UDIs in adverse event
reports that are required under part 803 (21 CFR part 803). This will
allow manufacturers and FDA to more rapidly review, aggregate, and
analyze related reports regarding a particular device, leading to more
rapid isolation and identification of the underlying problems, and
development of an appropriate solution to a particular concern.
    Provide for More Rapid, More Efficient Resolution of Device
Recalls. Delays in identifying recalled devices can result in the
continued use of those devices on patients and involves an

increased risk for patient harm. A device labeled with a UDI can be
identified rapidly and with great precision. The more rapidly a recall
is implemented and completed, the more rapidly the risks presented are
reduced or eliminated.
    Better Focused and More Effective FDA Safety Communication. By
citing UDIs, FDA will be able to more precisely focus safety alerts,
public health notifications, or other communications, eliminating
confusion with similar devices and allowing more rapid responsive
action. Users of similar devices that are not the subject of the safety
alert would be relieved of the uncertainty concerning whether they have
been exposed to, or are affected by, a problem or risk.
    Additional Benefits. FDA expects the UDI system will provide
additional benefits. For example, UDIs can be used in educational and
informational materials to allow readers to quickly obtain additional
information from the GUDID and other FDA databases; UDIs could play an
important role in inventory management; and UDIs may be useful in the
provision of high-quality medical services. UDIs and GUDID data, when
linked with other FDA data, will help identify alternative devices in
the event of a shortage and will contribute to better detection of
counterfeit devices.
    In addition, while not required, FDA anticipates that providers
will include the UDIs of a wide variety of devices in patients'
Electronic Health Records (EHRs) and Personal Health Records (PHRs).
This information will strengthen the health care community's ability to
identify the specific devices implanted into patients and will improve
response to postmarket surveillance activities, including adverse event
reporting and recalls. For example, this information will contribute to
the rapid identification of risks and benefits associated with a device
within specific subpopulations. By linking clinical detail and
information regarding device use, more effective device safety
surveillance and evaluation studies could be conducted, contributing to
a more complete safety and effectiveness profile for devices and
enabling more appropriate and timely remedies when potential safety
concerns are identified.
    Standard Format for Dates Provided on a Device Label. The rule will
also better ensure dates on device labels are not confusing or
misleading to users thereby ensuring the safe use of devices, by
requiring that dates on medical device labels conform to a standard
format consistent with international standards and international
practice--year-month-day (e.g., 2013-09-30). This will ensure dates on
medical device labels are unambiguous and clearly understood by device
users.

Summary of the Major Provisions of the Regulatory Action in Question

    This rule will require the label and device packages of medical
devices to include a UDI, except where the rule provides for an
exception or alternative placement. Each UDI must be provided in a
plain-text version and in a form that uses AIDC technology. The UDI
will also be required to be directly marked on a device that is
intended for more than one use, and intended to be reprocessed before
each use. The rule requires the submission of information concerning
each device to the new GUDID. FDA plans to make most of the data
reported under this rule available to the public. The GUDID will not
include patient information. The rule will also require dates on device
labels and packages to be presented in a standard format that is
consistent with international standards and international practice.
    The UDI system established by this rule builds on international
regulatory cooperation activities and makes use of internationally
recognized standards relating to unique identification and data
exchange. The rule specifies the technical requirements of a UDI. Each
UDI will consist of two portions:
     A device identifier that corresponds to the specific
version or model of the device and the labeler of the device (the
labeler is the 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 introduced into interstate commerce without any subsequent
replacement or modification of the label; in most instances, the
labeler would be the device manufacturer, but the labeler may be a
specification developer, a single-use device reprocessor, a convenience
kit assembler, a repackager, or a relabeler), and
     A production identifier that more precisely identifies the
specific device by providing variable information, such as the lot or
batch, the serial number, expiration date, the date of manufacture,
and, for human cells, tissues, or cellular and tissue-based products
(HCT/Ps) regulated as devices, the distinct identification code
required in Sec.  1271.290(c) (21 CFR 1271.290(c)).
    The rule explains when a UDI is required and when its use must be
discontinued. The rule requires all UDIs to be issued under a system
operated by an FDA-accredited issuing agency. The rule provides a
process through which an applicant would seek FDA accreditation as an
issuing agency, specifies the information that the applicant must
provide to FDA, and the criteria FDA will apply in evaluating
applications. The rule provides for the suspension and revocation of
the accreditation of an issuing agency, and explains the circumstances
under which FDA will, or may, act as an issuing agency.
    Whenever a device must bear a UDI, the labeler of that device is
required to submit information concerning the device to the GUDID,
which will facilitate the rapid identification of the device and the
labeler and provide links to other FDA data. FDA plans to make this
information available to the public through a variety of channels.
    The rule provides for certain exceptions and alternatives, ensuring
that the costs and burdens are kept to a minimum.
    As discussed in Section VII.B, ``Compliance Dates,'' FDA has
established a set of compliance dates that will phase-in the
requirements of this rule in stages, over a period of 7 years, to
ensure a smooth implementation and to spread the costs and burdens of
implementation over time, rather than having to be absorbed all at
once.

Costs and Benefits

                                                 Economic Data: Costs and Benefits Accounting Statement
                                                                     [2012 dollars]
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                                                                                Units
                                                                                ---------------------------------------------------------------
               Category                    Primary estimate         Low          High                    Discount
                                                                  estimate     estimate       Year         rate        Period             Notes
                                                                                dollars     (percent)     covered
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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.
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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  ...........  .......................
                                       .......................  ...........  ...........  ...........            3  ...........  .......................
    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                                                                                .......................
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Table of Contents

I. Background
II. Comments on the Proposed Rule and FDA's Responses
    A. Definitions--21 CFR 801.3, 803.3, 806.2, 810.2, 814.3, 820.3,
821.3, 822.3, and 830.3
    B. Applicability of Sec.  801.20
    C. Compliance Dates of Unique Device Identifier Regulatory
Requirements
    D. Formatting of Dates Provided on Medical Device Labels--Sec.
801.18
    E. General Exceptions from the Requirement for the Label of a
Device to Bear a Unique Device Identifier--Broad Comments Concerning
Proposed Sec.  801.30
    F. General Exceptions from the Requirement for the Label of a
Device To Bear a Unique Device Identifier--Exception for a Device,
Other Than a Prescription Device, That Is Made Available for
Purchase at a Retail Establishment, Including Such a Device
Delivered Directly to a Hospital, Ambulatory Surgical Center,
Nursing Home, Outpatient Treatment Facility, or Other Health Care
Facility. Proposed Sec.  801.30(a)(1)
    G. General Exceptions from the Requirement for the Label of a
Device To Bear a Unique Device Identifier--Exception for Existing
Inventories of Finished Devices That Have Been Labeled Prior to the
Applicable Compliance Date--Final Sec.  801.30(a)(1)
    H. General Exceptions from the Requirement for the Label of a
Device To Bear a Unique Device Identifier--Exception for Class I
Devices That FDA Has Exempted from Good Manufacturing Practices--
Sec.  801.30(a)(2)
    I. General Exceptions from the Requirement for the Label of a
Device To Bear a Unique Device Identifier--Exception for Individual
Single-Use Devices, All of a Single Version or Model, That Are
Distributed Together in a Single Device Package--Sec.  801.30(a)(3)
    J. General Exceptions from the Requirement for the Label of a
Device to Bear a Unique Device Identifier--Exception for a Custom
Device Within the Meaning of Sec.  812.3(b)--Sec.  801.30(a)(5)
    K. General Exceptions from the Requirement for the Label of a
Device To Bear a Unique Device Identifier--Exception for a Device
Intended for Export from the United States--Sec.  801.30(a)(8)
    L. General Exceptions from the Requirement for the Label of a
Device To Bear a Unique Device Identifier--Exception for a Device
Packaged Within the Immediate Container of a Combination Product or
Convenience Kit--Similar Requirements Proposed at Sec.  801.25;
Revised Requirements at Sec.  801.30(a)(11)
    M. Medical Procedure Kits and Trays

    N. General Exceptions from the Requirement for the Label of a
Device To Bear a Unique Device Identifier--Exception for a Device
Held by the Strategic National Stockpile and Granted an Exception or
Alternative Under Sec.  801.128(f)(2)--Sec.  801.30(a)(9)
    O. General Exceptions from the Requirement for the Label of a
Device To Bear a Unique Device Identifier. The Unique Device
Identifier of a Class I Device Is Not Required to Include a
Production Identifier--Sec.  801.30(c)
    P. Requests for Additional General Exceptions from the
Requirement for the Label of a Device To Bear a Unique Device
Identifier
    Q. Request for Modification of Unique Device Identifier Labeling
Requirements for Devices That Have Small Labels
    R. Voluntary Labeling of a Device With a Unique Device
Identifier--Proposed Sec.  801.40; Revised Requirements at Sec.
801.35
    S. Form of a Unique Device Identifier--Technical Requirements--
Proposed Sec.  801.45(a); Sec.  801.40(a) of the Final Rule
    T. Form of a Unique Device Identifier--Unique Device Identifier
to Include Device Identifier and Production Identifier--Proposed
Sec.  801.45(b); Revised Requirements at Sec.  801.40(b) of the
Final Rule
    U. Form of a Unique Device Identifier--Proposed Symbol to
Indicate the Presence of Automatic Identification and Capture
Technology--Proposed Sec.  801.45(c); Revised Requirements at Sec.
801.40(c) of the Final Rule
    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
    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
    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)
    Y. Revision of Direct Marking Requirements--Proposed Sec.
801.50; Sec.  801.45 of the Final Rule
    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)
    AA. Requirements for Stand-Alone Software--Final Sec.  801.50
    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
    CC. Discontinuation of Legacy Identification Numbers Assigned to
Devices (National Drug Code and National Health-Related Item Code
Numbers)--Sec.  801.57
    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
    EE. Human Cells, Tissues, or Cellular or Tissue-Based Products
That are Regulated as Devices--Sec. Sec.  801.3 and 801.20(a)(1)
    FF. Technical Standards Applicable to Part 830--Sec.  830.10
    GG. Requirements for a Unique Device Identifier--Sec.  830.20
    HH. Use and Discontinuation of a Device Identifier--Sec.  830.40
    II. Changes That Require Use of a New Device Identifier--Sec.
830.50
    JJ. FDA Accreditation of an Issuing Agency--Sec.  830.100
    KK. Information Required for Unique Device Identification--Sec.
830.310
    LL. Information Required for Unique Device Identification--
Information Concerning Each Version or Model of a Device--Sec.
830.310(b)
    MM. Enforcement Authority
    NN. Questions and Comments Suggesting the Need for Additional
Guidance
    OO. Requests for Additional Opportunity for Comment Prior to
Issuing a Final Rule
III. Legal Authority for the Final Rule
IV. Analysis of Impacts
    A. Summary of Impacts
    B. Summary of Regulatory Flexibility Analysis
    C. Summary of Benefits
V. Information Collection Requirements
VI. Environmental Impact
VII. Effective Dates
    A. Effective Dates
    B. Compliance Dates
VIII. Federalism
IX. References

I. Background

    On July 10, 2012, FDA published a proposed rule to establish a
unique device identification system, as required by section 519(f) of
the FD&C Act (see 77 FR 40736). On July 9, 2012, FDASIA was signed into
law; section 614 of FDASIA amended section 519(f) of the FD&C Act,
requiring modification of the timeframe for implementation of the
proposed rule's requirements as they apply to devices that are
implantable, life-saving, or life-sustaining. On November 19, 2012, FDA
published a document amending our July 10, 2012, proposed rule to meet
the requirements of amended section 519(f) of the FD&C Act (see 77 FR
69393).
    The preamble to the July 2012 proposal describes the objectives of
the rule (see 77 FR 40736 at 40740 through 40743), and we refer readers
to that preamble if they wish to obtain details on the events,
recommendation, meetings, and literature that shaped the development of
the proposed rule. The preamble to the November 2012 amended proposal
describes changes that were required by the enactment of FDASIA,
including revision of the compliance dates proposed for implantable,
life-supporting, and life-sustaining devices.
    We received approximately 270 submissions of comments from
approximately 225 sources (some submitted more than one set of
comments)--individuals (health care professionals, academics,
consumers, and others), organizations (consumer groups, hospitals,
health care associations, military and government sources, and others),
and private industry (device manufacturers, industry associations,
distributors, and others). These comments provided approximately 1,700
pages of feedback and commentary concerning the proposed rule. Almost
all comments supported the objectives of the rule in whole or in part.
For example, one comment stated it ``strongly supports'' the
implementation of a UDI system, and that ``UDI is the missing link to
protect patient safety.'' Another comment stated, ``We support FDA's
objective to substantially reduce existing obstacles to the adequate
identification of medical devices used in the United States. We agree
that a medical device identification system has the potential to
rapidly and definitively identify a medical device and the key
attributes that could affect its safe and effective use.'' The great
majority also suggested changes to the proposed rule, stating, for
example, that they were ``providing comments on this proposed rule, and
we wish to voice our support of the efforts to implement the regulatory
framework for a unique device identification system.'' Some of the
suggested changes were very minor and others were very broad and
sweeping. Comments suggesting changes to the proposed rule and FDA's
responses are discussed later in this document.
    After reviewing the comments, FDA made several changes to the rule.
The principal changes between the amended proposed rule of November 19,
2012, and this final rule are as follows:

    Table 1.--Principal Changes between the Amended Proposed Rule of
                 November 19, 2012, and This Final Rule
------------------------------------------------------------------------
     Proposed Rule (As Amended)                   Final Rule
------------------------------------------------------------------------
The proposed rule used the term      The final rule uses ``compliance
 ``effective date'' in an incorrect   date'' to explain when a labeler
 manner when denoting the dates by    is required to comply with a
 which a labeler would have to        regulatory requirement. The final
 comply with certain provisions. A    rule has only two effective dates:
 consequence of setting an            The final rule is effective 90
 effective date for a particular      days after publication (December
 requirement is that the              23, 2013), except Sec.  Sec.
 requirement will not be published    801.55, 830.10, 830.100, 830.110,
 in the Code of Federal Regulations   830.120, and 830.130 are effective
 (CFR) until the effective date has   30 days after publication (October
 passed. This would have made it      24, 2013).
 very difficult for labelers to      To clarify changes from the
 understand and comply with the       proposed rule to the final rule,
 final rule, for example because      we use the term ``compliance
 the CFR would not have provided      date'' throughout this document
 the full text of the regulatory      wherever the proposed rule
 requirements of a final rule for     incorrectly used ``effective
 several years. The proposed rule     date.''
 should have used the term           Section VII.B., ``Compliance
 ``compliance date'' to indicate      Dates,'' explains in detail the
 when a labeler would not be          compliance dates FDA has
 required to comply with certain      established for the final rule. A
 provisions.                          device does not have to comply
                                      with the final rule if it is in
                                      commercial distribution, see Sec.
                                       807.3(b) (21 CFR 807.3(b)), prior
                                      to the applicable compliance date.
The proposed rule did not explain    The final rule explains that FDA
 whether it would be possible to      may grant a 1-year extension of
 extend the 1-year compliance date    the compliance date applicable to
 applicable to a class III device     a class III device or a device
 or a device licensed under the       licensed under the Public Health
 Public Health Service Act in         Service Act when in the best
 circumstances where rapid            interest of the public health. See
 implementation of the rule could     the discussion in section VII.B,
 lead to device shortages or other    ``Compliance Dates.''
 significant problems.
The proposed rule did not explain    The final rule provides an
 how it would apply to inventories    exception for a finished device
 of devices manufactured and          that is manufactured and labeled
 labeled prior to the compliance      prior to the compliance date that
 date of the final rule.              applies to that device, but the
                                      exception expires 3 years after
                                      the compliance date that applies
                                      to the particular device. See Sec.
                                        801.30(a)(1).
Dates provided on device labels      Dates provided on device labels are
 would have been presented as Month   to be presented as Year-Month-Day,
 Day, Year, using a three-letter      with the year expressed as four
 abbreviation of the month (e.g.,     digits, the month expressed as two
 SEP 30, 2013). Proposed Sec.         digits, and the day expressed as
 801.18.                              two digits (e.g., 2013-09-30).
                                      This format is consistent with
                                      international standards and the
                                      requirements of the European Union
                                      and other nations. See Sec.
                                      801.18.
The date formatting requirements of  The date formatting requirements of
 Sec.   801.18 would have gone into   Sec.   801.18 will have the same
 effect for all devices 1 year        compliance dates as UDI labeling
 after publication of a final rule.   requirements. If a device is not
                                      subject to UDI labeling
                                      requirements, the date formatting
                                      requirements of Sec.   801.18 will
                                      apply 5 years after the
                                      publication of this final rule.
                                      See the discussion in section
                                      VII.B, ``Compliance Dates.''
The proposed rule would have         The final rule provides that a
 provided an exception from UDI       class I device labeled with a
 labeling requirements for a          Universal Product Code (UPC) may
 device, other than a prescription    use the UPC as its UDI; see Sec.
 device that is made available for    801.40(d).
 purchase at a retail
 establishment, including such a
 device delivered directly to a
 hospital, ambulatory surgical
 center, nursing home, outpatient
 treatment facility, or other
 health care facility. Proposed
 Sec.   801.30(a)(1).
The proposed rule would have         The final rule excepts the device
 required certain combination         constituent part packaged within a
 products, and certain device         combination product from the
 constituent parts of every           requirement that its label bear a
 combination product, to bear a UDI   UDI, if the combination product
 on their label. Proposed Sec.        bears a UDI. Sec.   801.30(a)(11).
 801.25(a) and (b).
The proposed rule would have         The final rule does not require
 required the label and device        devices contained within a
 package of each device packaged in   convenience kit to bear a UDI but
 a convenience kit to bear its own    does require the label and each
 UDI, distinct from that of the       device package of every
 convenience kit, unless intended     convenience kit to bear a UDI.
 for a single use. Proposed Sec.      Sec.   801.30(a)(11).
 801.25(d).
The proposed rule would have         The final rule provides an
 provided an exception for a class    exception for a class I device
 I device that FDA has by             that FDA has by regulation been
 regulation exempted from the good    exempted (but for the continuing
 manufacturing practice               requirement for recordkeeping
 requirements of part 820. Proposed   under Sec.  Sec.   820.180 and
 Sec.   801.30(a)(2).                 820.198) from the good
                                      manufacturing practice
                                      requirements of part 820 of this
                                      chapter. See Sec.   801.30(a)(2).
The proposed rule would have         The final rule extends this
 provided an exception for            exception to all individual SUDs,
 individual class I single-use        regardless of class, except that
 devices (SUDs), all of a single      this exception is not available
 version or model, that are           for any implantable device. The
 distributed together in a single     device package containing these
 device package, and which are not    individual devices is not
 intended for individual sale.        excepted, and must bear a UDI. See
 Proposed Sec.   801.30(a)(3).        Sec.   801.30(a)(3).
The proposed rule would have         The final rule provides that a
 provided an exception for a device   device packaged within the
 constituent part of a combination    immediate container of a
 product, if the device constituent   combination product is excepted
 part is physically, chemically, or   from the requirements of Sec.
 otherwise combined with other        801.20 if the combination product
 constituents of the combination      bear a UDI.
 product in such a way that it is
 not possible for it to be used
 except as part of the use of the
 combination product. Proposed Sec.
   801.30(a)(11).

The proposed rule would have         The final rule also makes clear
 required a combination product for   that the device constituent of a
 which the primary mode of action     combination product whose
 is that of a medical device to       components are physically,
 bear a UDI on its label. Proposed    chemically, or otherwise combined
 Sec.   801.25(a).                    or mixed and produced as a single
                                      entity as described by Sec.
                                      3.2(e)(1) (21 CFR 3.2(e)(1)) is
                                      not subject to the requirements of
                                      Sec.   801.20 if the combination
                                      product properly bears a National
                                      Drug Code (NDC) number. See Sec.
                                      801.30(b)(2).
                                     The final rule provides that a
                                      combination product that properly
                                      bears a National Drug Code (NDC)
                                      number is not required to bear a
                                      UDI. See Sec.   801.30(b)(1).
                                      However, the final rule also makes
                                      clear that each device constituent
                                      of a combination product, other
                                      than one described by Sec.
                                      3.2(e)(1), that properly bears an
                                      NDC on its label must also bear a
                                      UDI on its label unless the
                                      combination product bears a UDI on
                                      its label. See Sec.
                                      801.30(b)(3).
The proposed rule would have         The final rule broadens and
 provided an exception for a device   simplifies this exception, and
 that is packaged in a convenience    extends it to the label of any
 kit, provided that the device is     device that is packaged in a
 intended for a single use.           convenience kit as long as the
 Proposed Sec.   801.30(a)(12).       label of the convenience kit bears
                                      a UDI. See Sec.   801.30(a)(11).
The proposed rule would have         The final rule renumbers proposed
 required use of a symbol to          Sec.   801.45 as Sec.   801.40.
 indicate the presence of AIDC        The final rule does not require
 technology, and provided a generic   use of a symbol to indicate the
 symbol that could have been used     presence of AIDC technology, no
 in lieu of any other symbol.         longer provides for use of a
 Proposed Sec.   801.45(c).           generic symbol, and instead
                                      requires only that a label
                                      ``disclose'' the presence of AIDC
                                      technology. See Sec.   801.40(c).
The proposed rule would have         This provision has been removed; an
 required an implantable device       implantable device will not be
 required to bear a UDI on its        required to be directly marked
 label to also bear a permanent       with a UDI.
 marking providing the UDI. See
 proposed Sec.   801.50(a)(1).
The proposed rule would have         The final rule renumbers proposed
 required a device required to bear   Sec.   801.50 as Sec.   801.45.
 a UDI on its label to also bear a    The final rule changes this
 permanent marking providing the      provision to apply to devices that
 UDI if the device is intended for    are ``reprocessed'' before each
 more than one use and must be        use; this broadens the scope of
 sterilized before each use. See      the provision. See Sec.
 proposed Sec.   801.50(a)(1).        801.45(a)(1).
The proposed rule did not fully      The final rule includes a new
 explain how UDI labeling             section that provides special
 requirements would apply to stand-   labeling requirements for
 alone software regulated as a        stand[dash]alone software
 medical device. Proposed Sec.        regulated as a medical device,
 801.50, concerning direct marking,   including:
 was the only provision that          An explanation of how
 specifically addressed stand-alone   stand[dash]alone software can meet
 software.                            UDI labeling requirements when it
                                      is not distributed in package form
                                      (e.g., when it is downloaded from
                                      a labeler's Web site);
                                      a requirement for all
                                      stand-alone software to include
                                      means of displaying its UDI; and
                                      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.
                                     See Sec.   801.50.
The proposed rule was not clear      The final rule provides a single
 regarding the process for            process for all types of requests,
 requesting an exception or           and provides a more comprehensive
 alternative to some UDI labeling     process. See Sec.   801.55. The
 requirements, and provided one       final rule adds these provisions:
 process for requests that concern    FDA may grant a 1-year
 the use of UDIs on a device label    extension of the compliance date
 and device package, proposed Sec.    applicable to class III devices
  801.35, and an entirely different   and devices licensed under the
 process concerning direct marking    Public Health Service Act; see
 of medical devices, proposed Sec.    Sec.   801.55(b), discussed
  801.50.                             previously;
                                      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; see
                                      Sec.   801.55(e);
                                      FDA may rescind an
                                      exception or alternative; see Sec.
                                        801.55(e);
                                      any labeler may make use
                                      of an exception or alternative
                                      that FDA has granted (FDA plans to
                                      make all decisions available to
                                      the public on FDA's Web site); see
                                      Sec.   801.55(d).
The proposed rule was unclear        The final rule explains that every
 whether the discontinuation of       NHRIC and NDC number assigned to
 legacy FDA identifiers for devices   any device (even a device that is
 (National Health-Related Item Code   not required to bear a UDI) will
 (NHRIC) and NDC numbers) would       be rescinded no later than
 apply to devices that are exempted   September 24, 2018. See Sec.
 from UDI labeling requirements.      801.57.
 Proposed Sec.   801.57.
The proposed rule did not explain    The final rule will permit
 how the discontinuation of legacy    continued use of an FDA-issued
 FDA identifiers would affect FDA-    labeler code under an FDA-
 issued labeler codes that are        accredited system for the issuance
 already in use in the private        of UDIs, provided that such use is
 sector and whose use might be        permitted by the issuing agency
 permitted under an FDA-accredited    that administers that system, and
 system for the issuance of UDIs.     provided the labeler submits a
                                      request for continued use of a
                                      labeler code; FDA must receive the
                                      request no later than September
                                      24, 2014. See Sec.   801.57(c).
The proposed rule more               The final rule gives labelers more
 prescriptively defined the types     flexibility to determine when a
 of changes that resulted in a new    change to a device will require
 version or model, and which          use of a new UDI. Sec.   830.50 is
 therefore required a new device      now entitled ``Changes that
 identifier to be used to identify    require use of a new device
 the changed device. See proposed     identifier.''
 Sec.   830.50, which was then
 titled ``Changes that result in a
 new version or model.''.

The proposed rule did not require    The final rule requires information
 information concerning magnetic      to be submitted to the GUDID
 resonance imaging (MRI)              concerning whether a patient may
 compatibility of a device to be      be safely exposed to MRI or
 submitted to the GUDID. See          similar technologies while using
 proposed Sec.   830.310(b).          the device or while the device is
                                      implanted in the patient. See Sec.
                                        830.310(b)(8).
The preamble to the proposed rule    The GMDN Agency has agreed to
 stated that the GUDID would not      provide free access to GMDN
 collect the Global Medical Device    nomenclature within the context of
 Nomenclature (GMDN) code for a       the GUDID data submission process.
 device under proposed Sec.           A labeler who reports data to the
 830.310(b) unless GMDN codes were    GUDID will be able to enter a GMDN
 made freely available.               code if the labeler knows it, or
                                      may use a module integrated in the
                                      GUDID reporting system to search
                                      for and select an appropriate GMDN
                                      term. See Sec.   830.310(b)(13).
The proposed rule did not explain    The final rule explains that FDA
 the process for correcting           may inform the labeler that
 misinformation submitted to the      information submitted to the GUDID
 GUDID.                               appears to be incorrect or
                                      potentially misleading, and
                                      request that the labeler correct
                                      the information or provide a
                                      satisfactory explanation of why it
                                      is correct. The labeler would have
                                      10 days to correct the information
                                      or explain why it is correct. If
                                      FDA determines that information is
                                      incorrect or could be misleading,
                                      we may delete or replace the
                                      information. See Sec.   830.350.
------------------------------------------------------------------------

    We describe and respond to the comments in section II of this
document. We have grouped comments into several broad topics that
reflect the primary concerns of similar comments, and have identified
the section or sections of the final rule (or the proposed rule, when
appropriate) that are most closely related to each topic. The order in
which each topic or comment is discussed is purely for organizational
purposes and does not signify a comment's value or importance.

II. Comments on the Proposed Rule and FDA's Responses

A. Definitions--21 CFR 801.3, 803.3, 806.2, 810.2, 814.3, 820.3, 821.3,
822.3, and 830.3

    FDA received many comments (approximately 42) suggesting changes
to, or clarification concerning, the definitions proposed for inclusion
in the rule.
    Convenience kit--A comment suggested we should restrict the scope
of this definition by including additional language: ``A group of
reusable devices bearing and identified by an ordering number,
appearing only on shipping container(s) and/or invoices, does not
constitute a convenience kit.''
    FDA does not agree that this additional language would clarify the
definition; rather, we believe this addition would be more likely to
confuse labelers than help them understand how the rule applies to
convenience kits. A convenience kit, or any other device subject to
this rule, may be identified by a wide variety of numbers or other
identifiers for a wide variety of purposes. The use of catalog numbers,
inventory numbers, ordering numbers, or any other identification number
is neither prohibited nor regulated by this rule, except that Sec.
801.57 rescinds certain legacy FDA identification numbers and requires
discontinuation of their use on a device label.
    Comments suggested FDA should ``remove all references to
convenience kits'' because kits (apart from their regulated device
parts) are not themselves devices subject to UDI. Commenters also
expressed concern that the requirement for a UDI on both components and
kits is duplicative. The same comments went on to suggest that, if the
final rule would apply to convenience kits, FDA should ``modify the
definition . . . to clarify that the term refers to convenience kits
that have been determined to be and are classified as a medical
device.''
    FDA does not agree that convenience kits should be excluded from
the final rule. Convenience kits are in wide use and are medical
devices in their own right, apart from their constituent devices; their
exclusion would leave a significant gap in the coverage of the rule and
would undermine the effectiveness of the UDI system because they are
controlled in the supply chain by the kit rather than by constituent
part. FDA removed proposed Sec.  801.25 from the final rule but only
because convenience kits are by definition devices and therefore are
required to meet UDI requirements. However, we do include an exception
for the label of devices contained within the immediate container of a
convenience kit at Sec.  810.30(a)(11).
    The final rule adopts the definition of convenience kit provided by
the proposed rule, without change. The final rule does, however,
include important changes that we believe address the underlying
concerns of these comments. Section 801.30(a)(11) now provides that the
label of devices packaged within the immediate container of a
convenience kit do not have to bear a UDI as long as the label of the
convenience kit bears a UDI. This change will make clear that labelers
do not have to change the way they label convenience kits, including in
vitro diagnostic kits, except for including a UDI on the kit label.
    Device package--We received several comments concerning this
definition and the application of the rule to device packages other
than the ``immediate container'' of the device. For example, one
comment suggested the definition is ``too broad and requires
clarification to ensure that is does not apply to a group of devices
that are shipped together only as logistics or shipping units such as
orthopedic trays.'' Another comment suggested that a UDI should be
required on ``regulated packaging'' and noted that manufacturers
commonly change quantities at higher levels of packaging for storage,
logistics, and transportation purposes. Another comment did not
specifically object to providing a UDI on varying device packages, but
did not see a need for different UDIs on device packages that contain
different quantities.
    FDA disagrees that the UDI rule should not apply to device packages
other than the immediate container, and that different device packages
should not be identified by different UDIs. UDIs on all device packages
are essential for rapid and efficient identification of devices that
are the subject of a recall, a key objective of the UDI rule. The use
of separate UDIs for higher level

packaging reflects prevailing industry practices (Refs. 3, 14, and 15).
Similarly, different UDIs are useful for each different device package
because a device recall might target a specific device package while
excluding other device packages; in addition, the requirement for
different UDIs on different device packages recognizes current industry
practices, which generally use different identifiers for each level of
packaging and for packages with different quantities of devices.
Accordingly, we have not modified the definition of device package in
response to comments. Because packages that contain a convenience kit,
an in vitro diagnostic product, an HCT/P regulated as a device, or a
combination product with a device constituent part all contain a
particular version or model of a device, such packages also meet the
definition of ``device package'' and are required to bear a UDI by
Sec.  801.20.
    Six comments argued that a UDI should be required to appear only on
the label of a device, and not on higher levels of packaging based on
the premise that section 519(f) of the FD&C Act narrowly requires a UDI
only on the device label.
    FDA disagrees with this comment. As explained in the preamble to
the amended proposed rule, the presence of a UDI on the higher-level
packaging of a device 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 (21 U.S.C. 360h), 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 (21 U.S.C.
351) and/or misbranded under section 502 (21 U.S.C. 352). Thus, the
provisions of the final rule requiring a UDI on higher-level packaging
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) (21 U.S.C. 371(a)) and its
specific authority to implement UDI requirements to identify devices
``through distribution and use'' of the device under section 519(f).
(See 77 FR 69393 at 69395.) Requiring a UDI on device packages enables
the UDI to serve its purposes of assisting with tracking, recalls, and
enforcement with respect to devices that have not yet been removed from
their package, for example for devices located at distributors or in
hospital inventory, while avoiding any need to open or tamper with the
device packaging.
    Finished device--We did not receive any comments concerning this
definition. This term is used in the definition of lot or batch, and is
included to clarify the meaning of that term. This term is also useful
when determining the ``date of manufacture'' that should be used as a
production identifier; see the discussion of Unique device identifier
(UDI)--Production identifier, in this document.
    HCT/P regulated as a device--We have added this definition, and
made other changes that are discussed later in this document, to
explain how the final rule applies to HCT/Ps that are regulated as
devices.
    Implantable device--Comments suggested FDA should remove the 30-day
threshold that restricts the direct marking requirement to devices
intended to remain implanted continuously for a period of 30 days or
more.
    Such a change would result in unwarranted inconsistency with
longstanding regulatory practice. For example, the definitions of
implant used in 21 CFR parts 812 (investigational device exemptions)
and 860 (medical device classification procedures) use the same 30-day
criterion. The final rule adopts the definition provided by the
proposed rule, without change. We note further that because FDA has
removed the requirement of direct marking for implants, the definition
of implantable device under the final rule is no longer relevant to the
scope of the direct marking requirement.
    Labeler--A comment suggested that the definition's use of language
referring to ``the intent that the device will be introduced into
interstate commerce'' is not appropriate. Another comment suggested
that the final rule should make clear that a health care system
assembling ``convenience kits'' for distribution within its own system
should not be a ``labeler'' and that such distribution is not
interstate commerce. A somewhat similar comment suggested that
``Hospitals, health care systems, and other entities that repackage
devices, assemble kits, or reprocess single-use devices for internal
use only . . . should not be subject to UDI-related requirements. . .
.''
    We believe that all of these concerns can be resolved by modifying
the definition to refer to ``commercial distribution,'' a term that has
been in use for many years and which is used extensively in FDA's
medical device regulations. The term ``commercial distribution'' is
defined by Sec.  807.3(b) and we intend for that definition to apply
here. ``Commercial distribution'' means any distribution of a device
intended for human use which is held or offered for sale, but does not
include internal transfer of a device between establishments within the
same parent, subsidiary, or affiliate company.
    Comments suggested FDA should modify the definition to include a
``relabeler'' or should define ``relabeler.''
    FDA agrees a relabeler is a labeler under this rule. We expected
that our use of ``modified'' in paragraph (2) of the definition would
have been understood to include ``replaced.'' FDA does not believe that
introducing the term ``relabeler'' would provide greater clarity.
Instead FDA believes we can better clarify our intended meaning by
amending paragraph (2) of the definition to begin, ``Any person who
causes the label of a device to be replaced or modified. . . .'' The
final rule adopts this change.
    Another comment suggested that the final rule ``must more
specifically describe when a repackager, device reprocessor, or other
non-manufacturer would be . . . considered a `labeler' for UDI
purposes.''
    FDA disagrees. This rule is not changing the meanings of repackager
or reprocessor; those terms will have the same meanings as they now
have within other regulatory contexts, such as registration and listing
and premarket review, and thus would be considered labelers.
    Lot or batch--A comment requested clarification regarding how this
term should be applied to HCT/Ps, ``where the donor identification is
of singular importance.'' Other comments mirrored this concern, stating
that devices ``derived from human tissue cannot be labeled by lot or
batch, unless the lot or batch identification is associated with a
single donor, as [21 CFR] 1271.220(b) disallows the pooling of human
cells or tissue from two or more donors during manufacturing.''
    FDA agrees that these are valid concerns, but we believe that the
phrases ``manufactured under essentially the same conditions'' and
``intended to have uniform characteristics and quality within specified
limits'' in the definition of lot or batch are flexible enough to
include the distinct identification code required by Sec.  1271.290(c).
FDA has, however, addressed the concerns of these comments in another
way. To clearly accommodate HCT/Ps regulated as devices, the final rule
includes additional language in the definition of production identifier
(part of the definition of unique device identifier);

this change is discussed in this document.
    Shipping container--We did not receive any comments suggesting
changes to this definition, but we have included minor edits in the
definition provided in the final rule. Deletion of the words
``package'' and ``pallet,'' is meant to help to simplify the definition
and avoid any confusion involving the defined term device package.
These edits are not intended to change the meaning of the term.
    Specification--A comment suggested that it would be better to
define this term to mean a requirement with which a device must conform
as documented in the Device Master Record consistent with Sec.  820.30,
Design controls.
    FDA disagrees. The definition we proposed is built on language
drawn from the Quality Systems Regulation, is consistent with existing
practice, and is clear. The final rule adopts the definition provided
by the proposed rule, without change.
    Unique device identifier (UDI)--A comment suggested, ``If HCT/Ps
regulated as medical devices are subject to the rule, we believe the
donation identification number must also be considered a production
identifier.'' The concern underlying this comment is similar to that of
a comment cited previously, concerning lot or batch.
    FDA agrees that this definition needs to be modified to address
existing practices concerning the labeling and tracking of HCT/Ps
regulated as devices. Accordingly, the final rule adds language to the
definition of production identifier, which is part of the definition of
unique device identifier (UDI). At the end of paragraph (2), we have
added the following additional production identifier: ``(v) For an HCT/
P regulated as a device, the distinct identification code required by
Sec.  1271.290(c).''
    Unique device identifier (UDI)--Production identifier. Comments
requested clarification concerning one type of production identifier,
the ``date a specific device was manufactured.'' For example, one
comment stated that ``it would be beneficial for FDA to clarify . . .
which date FDA is referring to (i.e., date of assembly, product date,
release date, etc.).''
    FDA believes it is the responsibility of each labeler to determine
the most appropriate date to use for each specific device, and to be
consistent in application of that policy.
    That said, FDA has provided a definition of finished device that we
believe provides a sound benchmark when determining the date of
manufacture.
    A comment suggested that stand-alone software should be able to use
its version number as its production identifier.
    We agree that for stand-alone software, the version number falls
within the meaning of lot or batch, which is one type of production
identifier. Therefore, when the labeler of stand-alone software
includes a version number on the label, it must be conveyed by the
production identifier. Further, because it is important for the version
number to be included in stand-alone software that is not distributed
in packaged form, we are adding a requirement to Sec.  801.50(a) that
the version number must be conveyed as part of the production
identifier for such software.
    Universal product code (UPC)--We did not receive any comments
concerning this definition, but we have included a minor edit in the
definition used in the final rule. The revised definition refers only
to identification of ``an item sold at retail in the United States.''
Reference to use of a UPC to identify the company associated with an
item has been removed because this rule focuses on the adequate
identification of devices, not companies.
    Version or model--A comment stated: ``The definition says that
version or model means a package. This is not easy to follow because
version or model normally refers to a device.''
    FDA agrees. The final rule adopts a definition that we believe is
clearer and better reflects the common understanding of this term. The
final rule removes the reference to a ``device package.'' The final
rule defines version or model to mean ``all devices that have
specifications, performance, size, and composition, within limits set
by the labeler.''
    Undefined terms--A few comments suggested that additional terms
should be defined to clarify the scope and intent of the rule. For
example, a few comments stated that FDA has not clearly defined the
term ``device.''
    Although the proposed rule did not provide a definition of
``device,'' none is required. ``Device'' is defined by statute, (see
section 201(h) of the FD&C Act (21 U.S.C. 321(h)), has been in common
use for decades, and has been a core concept inherent in every medical
device regulation ever issued. Its meaning should be clear to every
person affected by this rule. This rule does not require any further
definition or clarification of this term, and the final rule does not
include a definition of ``device.''
    Another comment suggested FDA should define ``device accessory.''
    FDA disagrees. Section 201(h) of the FD&C Act makes clear that the
term ``device'' includes an accessory. No other medical device
regulation has defined ``accessory'' (the term is defined within the
context of radiological health; see 21 CFR 1020.30(b)), and the final
rule does not include any requirement that specifically applies only to
an accessory to a device and does not distinguish between accessories
and other devices in any way.
    A comment pointed out that FDA has not defined ``direct mark.''
    We believe the meaning of this phrase is made clear by the language
of Sec.  801.45 in the final rule, and we specifically direct readers
to Sec.  801.45(c), Form of a UDI when provided as a direct marking.
    A comment that was primarily concerned with medical procedure kits
(discussed later in this document) suggested FDA should provide
definitions for ``set,'' ``kit,'' ``tray,'' and ``pack.''
    The final rule provides definitions for convenience kit and device
package. We do not believe the additional definitions are needed, and
we believe section II. M., ``Medical Procedure Kits and Trays''
provides adequate information for a reader to understand how these
items are regulated under the final rule.
    Because FDA does not agree that any of the suggested additional
terms need to be defined for an understanding of this rule, the final
rule includes only one additional term that was not included in our
July 10, 2012, proposed rule: ``HCT/P regulated as a device'', which is
discussed previously.

B. Applicability of Sec.  801.20

    There were a number of comments regarding the applicability of the
UDI requirements of Sec.  801.20 to combination products with a device
constituent part, convenience kits, in vitro diagnostic products, and
HCT/Ps regulated as devices.
    These products are devices, contain devices, or are regulated as
devices, and are therefore subject to the requirements of this rule.

C. Compliance Dates of Unique Device Identifier Regulatory Requirements

    FDA received many comments (approximately 100) suggesting changes
to the compliance dates we proposed in our July 10, 2012, proposed rule
and November 19, 2012, amended proposed rule (mistakenly referred to as
``effective dates'' in the proposed rule and amended proposed rule).
Roughly one-third of the comments that expressed a specific view
recommended a more

rapid implementation of the rule's requirements in order for the rule's
benefits and goals to be more rapidly achieved; for example, these
comments suggested the proposed phased implementation timeframe is
``far too long,'' that the rule's requirements should go into effect
``quickly--not years from now,'' and that ``UDI needs to be implemented
as quickly as possible.'' Roughly two-thirds recommended FDA allow more
time in order to better manage the tasks required to meet the rule's
requirements and to spread the costs of implementation over a longer
period of time; for example, these comments suggested that FDA should
``reconsider the schedule for implementation . . . as some of the
defined time periods are not possible for companies that may have
thousands of products containing various levels of packaging,'' and
that ``the proposed effective dates [meaning compliance dates] do not
allow adequate time to prepare to meet the rule's requirements.''
    Several comments suggested that the compliance date of Sec.  801.18
should be tied to the date the device must bear a UDI on its label; for
example, a comment suggested that the compliance date of Sec.  801.18
should be ``aligned with the date the label of the device must bear a
UDI.''
    FDA agrees with these comments, and we have established a set of
compliance dates that are the same for Sec.  801.18 and the rule's UDI
labeling requirements. This avoids the need to change a device label
more than once to implement the rule's requirements. We discuss the
comments on Sec.  801.18 and provide a full response in section II.D,
``Formatting of Dates Provided on Medical Device Labels--Sec.
801.18.''
    Section VII.B, ``Compliance Dates,'' explains the compliance dates
FDA has established for this and other provisions of the final rule.
This section makes clear that the requirements of the rule apply to
devices put in commercial distribution after the applicable compliance
date, and not to devices put in commercial distribution prior to such
date. As discussed in section II.A in the context of the definition of
``labeler,'' commercial distribution is defined at Sec.  807.3(b) and
the same meaning applies here.
    Several comments suggested several changes to the timeframes
proposed in our July 10, 2012, proposed rule and our November 19, 2012,
amended proposed rule. The specific changes suggested varied
considerably. For example, comments suggested several different ways to
implement the requirements for UDI labeling and GUDID reporting.
Comments suggested that all devices should be subject to these
requirements within 2 years, or 3 years. Other comments suggested that
class II devices should be subject to these requirements after 3 years,
or 5 years, or 7 years; that class III devices should be subject to
these requirements after 1 year, or 2 years, or 3 years, or 5 years;
that class I devices should be subject to direct marking requirements
after 5 years instead of 7 years. A comment suggested that the
implementation timeframe be tied to each issuing agency's
``establishment and communication of processes to support the . . .
Rule.'' We also received comments that simply recommended we implement
the rule's requirements more quickly, or to allow more time for
implementation, or to provide ``adequate'' time, but without suggesting
specific timeframes. One comment suggested that if the compliance dates
were not delayed ``for several years,'' the rule should be reproposed.
Other comments agreed that the phased in implementation proposed by FDA
would minimize the burdens. A comment stated that the proposed timeline
for implementation of direct marking requirements is ``reasonable and
necessary,'' and another comment agreed that it is reasonable to
require submission of GUDID data on the date a device must bear a UDI
on its label.
    Some comments were particularly concerned about requirements that
would apply 1 year after publication of a final rule--The date
formatting requirements of Sec.  801.18 and the requirements for UDI
labeling and GUDID reporting for class III devices. The comments
concerning Sec.  801.18 are discussed previously. Several comments
concerning the compliance dates for class III devices requested more
time; for example, a comment stated that the compliance date for class
III devices ``should be extended to 2 years from the date the rule is
finalized'' because the proposed 1-year timeframe ``may not allow
enough time for manufacturers to comply with the UDI requirements if
their product portfolio contains a large number of those products.''
Other comments stated that revision of labeling ``will be extensive and
time consuming,'' that labelers will need more time ``for the
preparation and submission of device related data,'' and that the
``timeframe . . . for class III device manufacturers to submit . . .
data to the GUDID is too short. We believe the deadline . . . should be
extended an extra year.''
    In summary, while many comments wanted some change to the
implementation schedule proposed by FDA, there were many different
views concerning the precise timeframe those changes should take
effect. Some comments recommended that labelers should be allowed to
comply with the date formatting requirements of Sec.  801.18 and basic
UDI labeling requirements (labeling requirements other than direct
marking) on the same date. On this latter comment, FDA agrees, as
discussed in more detail in this document.
    However, FDA does not agree with any comment that seeks broad
changes to the proposed timeframes for implementation of UDI labeling
or GUDID reporting requirements. Overall, we believe the schedule laid
out in the amended proposed rule not only meets the statutory
requirements of FDASIA, but also strikes a realistic balance between
desires to quickly see benefits from the UDI system and the challenges
that must be met to design, deploy, and test the systems that will be
required to meet the new regulatory requirements and for effective and
efficient administration of UDI processes. FDA also continues to
believe that the implementation timeframe should be tied to the risk of
the device. Consequently, FDA is establishing compliance dates as
proposed in our amended proposed rule, except, as discussed previously,
we have changed the compliance date of Sec.  801.18 to coincide with
the date a device must bear a UDI on its label.
    There were 24 comments specifically requesting FDA to extend the 1-
year compliance date for Class III devices, mostly to 2 years and
mostly because the 1-year timeframe is inadequate to locate, rework,
and validate new labeling for disparate inventories of existing
devices. Separately three comments warned of possible withdrawal or
export of non-complying inventory devices and resulting domestic
product shortages if UDI requirements were imposed on inventory
devices. We have addressed the latter concern by excepting inventory
devices for an additional 3 years, during which time these devices can
remain on the market without having to comply with UDI requirements.
See revised Sec.  801.30(a)(1) of the final rule; section II.G
(Exception for Existing Inventories of Finished Devices That Have Been
Labeled Prior to the Applicable Compliance Date) of this document.
Although FDA is not aware of anything to substantiate, specifically,
that the 1-year implementation timeframe for class III devices could
lead to shortages, FDA has included a new process in the final rule
through which FDA may, on our own initiative or upon the written

request of the labeler of a class III device or a device licensed under
the Public Health Service Act, grant a 1-year extension of the
compliance dates for UDI labeling and GUDID reporting when FDA
determines that the extension would be in the best interest of the
public health. For example, if the sole labeler of a particular class
III device provides information showing that it will not be able to
comply with UDI labeling requirements within the 1-year timeframe, and
showing that a medical device shortage will result if it is unable to
continue to ship the device until such time as it can comply with UDI
labeling requirements, FDA would consider an extension of the 1-year
compliance date. The process for requesting this extension is explained
in Sec.  801.55(b) of the final rule. FDA believes the availability of
this limited exception will allow appropriate flexibility in
implementing the final rule, while making it clear that FDA expects
most class III devices will remain subject to the 1-year compliance
date established by FDA in this document.
    Several comments requested clarification concerning whether or when
the rule would apply to devices manufactured and labeled prior to the
applicable compliance date, or suggested that the final rule should
provide an exception for such devices; for example, one comment
suggested the rule should provide ``an exception for all medical
devices which have been manufactured prior to the issue of the final
rule.''
    FDA agrees that it is important to take into account these
concerns, and we have done so by providing a limited exception in Sec.
801.30(a)(1) of the final rule. We discuss comments on this topic and
provide a full response in section II. G., ``General Exceptions From
the Requirement for the Label of a Device To Bear a Unique Device
Identifier--Exception for Existing Inventories of Finished Devices That
Have Been Labeled Prior to the Applicable Compliance Date--Final Sec.
801.30(a)(1).''
    Comments suggested that the proposed rule was not clear when the
conforming amendments to parts other than 801 and 830 take effect.
Under the amended proposed rule, and this final rule, any provision
that does not have a more specific effective date would go into effect
90 days after publication of a final rule. One comment also suggested
that there is not an immediate need to implement the amendments to part
820, Quality System Regulation, and part 822, Postmarket Surveillance,
as ``there will be few UDIs to track,'' and that changes to computer
systems will need validation.
    FDA does not agree that there is a need to provide a different
compliance date for the conforming amendments to parts other than 801
and 830. The proposed rule pointed out that some provisions that go
into effect 90 days after publication of the final rule ``will have no
practical effect'' until other provisions must be complied with. That
is the case here. For example, the amendments to parts 820 and 822 will
have no practical effect until 1 year after publication of the final
rule, when class III devices become subject to UDI labeling
requirements. We believe that this provides adequate time to prepare to
meet the requirements added to these parts.
    We received comments on the implementation timeframe for direct
marking of implantable devices under proposed Sec.  801.50(a)(1).
    Because we decided to withdraw this proposed requirement, there is
no need to discuss comments on the proposed implementation timeframe.
We discuss other comments on proposed Sec.  801.50(a)(1) and provide a
full response in section II.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.''
    We received a few comments objecting to the compliance date FDA
proposed in our November 19, 2012, amended proposed rule as applied to
implantable, life-supporting, and life-sustaining devices. These
comments disagreed with FDA's interpretation of section 614 of FDASIA
to require compliance with the rule within 2 years of publication of a
final rule for three categories of devices--devices that are
implantable, devices that are life-sustaining, and devices that are
life-saving (life-supporting). These comments interpret section 614 of
FDASIA to require the final rule to apply to a single category of
device that is at once implantable, life-sustaining, and life-saving.
    FDA disagrees with these comments. Although the statute uses the
conjunctive ``and'' and not the disjunctive ``or,'' the phrasing is
ambiguous, and it is reasonable to interpret the requirement to apply
conjunctively to all three categories of devices, as detailed in the
preamble to the amended proposed rule. There is no legislative history
indicating a Congressional intent inconsistent with this
interpretation.
    Further, regardless of whether these changes to section 519(f) of
the FD&C Act made by section 614 of FDASIA apply to one or three
categories of devices, FDA's implementation of this rule complies with
the statute since the single category preferred by the comments is
included within each of FDA's three categories, and it is within FDA's
authority to change the compliance date for UDI requirements to apply
to different categories of devices. This includes accelerating the
compliance date for devices that are implantable, devices that are
life-sustaining, and devices that are life-saving or life-supporting,
all of which are of particular importance from a public health
standpoint and thus have been singled out in several places in the FD&C
Act for heightened oversight, as explained in the preamble to the
proposed rule. Thus the final rule adopts the compliance dates proposed
in our November 19, 2012 amended proposed rule for implantable, life-
supporting, and life-sustaining devices (see table 6).

D. Formatting of Dates Provided on Medical Device Labels--Sec.  801.18

    FDA proposed that all dates provided on a medical device label that
are ``intended to be brought to the attention of the user of the
device. . .shall be presented in the following format: Month Day, Year
(e.g., JAN 1, 2012).'' We also proposed that labelers would have to
comply with the requirements of proposed Sec.  801.18 1 year after
publication of a final rule. FDA received many comments (approximately
110) on the proposed date format and the proposed compliance date of
the date format. Nearly all of these comments opposed the proposed date
format, considered the time provided to implement this labeling change
to be inadequate, or both. Although many comments recognized the
benefits of standardized dates, most viewed FDA's proposal as too
restrictive, too burdensome, inconsistent with the needs of
international commerce, and inconsistent with existing industry
practices. Comments noted that FDA's proposed date format would require
different labels for a device when marketed in the United States and
the same device when marketed in the European Union or other
international markets. For example, comments noted that the date format
required by the proposed rule ``is not consistent with global
requirements'' and ``perpetuates an opportunity for confusion'' by not
implementing ``standardized international dating systems.''
    FDA agrees with these comments and has revised Sec.  801.18 as
discussed in this document.
    One comment suggested that FDA should permit a manufacturer to use
any date format it chooses, ``as long as the

manufacturer makes clear'' what format it is using, and a similar
comment suggested FDA should ``should allow for multiple data formats''
but should give ``priority . . . to international standards.'' Several
comments suggested that FDA should permit truncated dates, using only
the year and month (YYYY-MM). This is one of the formats permitted
under some international standards, such as International Organization
for Standardization (ISO) 8601:2004, that were cited by comments.
    FDA disagrees with all of these suggestions. Any approach that
allows for multiple formats would require patients and health care
professionals to spend time and effort to determine how a given
labeler's dates should be interpreted. A date format that provides only
the year and month could still leave users uncertain as to whether an
expiration date refers to the first day of the month, or the last day
of the month. This is little different from the current situation,
where variation in the presentation of date confuses users and can lead
to incorrect decisions, such as determining whether a device has
reached an expiration date.
    FDA agrees with a comment that suggested a ``single specified date
format will reduce confusion'' concerning interpretation of dates on
medical device labels, and with the many comments that suggested that
FDA should abandon its proposed date format and should instead adopt a
date format specified in an international standard, such as ISO
8601:2004, and consistent with international usage, including that of
the European Union. If all dates were formatted in this way, ``one
label can be used globally for all product identification.'' These
comments were consistent with a comment that suggested, ``The
manufacturing date, expiration date, and any other necessary date
should be written as YYYY-MM-DD to harmonize with the ISO 8601
requirements.'' FDA agrees, and the final rule provides that all dates
on medical device labels intended to be brought to the attention of the
user must be presented as year-month-day (for example, 2013-09-30). FDA
does not, however, agree with comments that suggested we should
incorporate ISO 8601:2004 or any other international standard, because
the standards we examined all permit multiple formats, for example, by
permitting dates that use only the year and month (YYYY-MM), and
truncated dates are not permitted by the final rule. In the event that
a medical device expires in a particular month, but not a particular
date, the labeler may choose the last day of the month for the date
field.
    Proposed Sec.  801.18(f) provided that for a device that 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). One comment suggested
the date format proposed in Sec.  801.18 should also apply to those
products.
    FDA does not agree. Section 1010.3(a)(2)(ii) provides a consistent
date format, specifies that the date is the date of manufacture, has
been the standard practice for many years, and has proven to be
adequate for electronic products regulated under subchapter J. At this
time, no need for an alternative approach for electronic products has
been shown. Section 801.18(b) of the final rule provides an exception
for an electronic product to which a standard is applicable under
subchapter J, and such devices will continue to be required to present
the date of manufacture as provided by Sec.  1010.3(a)(2)(ii).
    A few comments suggested that the date format should not apply to
data communicated by AIDC technologies (e.g., bar codes and
radiofrequency identification (RFID)).
    FDA agrees that we should not attempt to regulate how data is
communicated by AIDC technologies, or the order in which specific
information is communicated by AIDC.
    In response to comments that suggested the proposed 1 year
compliance date for Sec.  801.18 ``does not provide adequate time'' to
make label changes for all devices covered by the rule, FDA is
establishing compliance dates for Sec.  801.18 that will phase in the
date format requirement at the same time as the UDI labeling goes into
effect for a particular device. This will reduce the costs and burdens
of the final rule by allowing both the date format and UDI labeling
changes to be made in a single revision.
    A comment, though generally very supportive of the UDI proposed
rule, argued that the FD&C Act, and section 510(e) (21 U.S.C. 360(e))
in particular, does not provide authority for the uniform date format
provision, noting that the legal authority section of the proposed rule
did not specifically explain FDA's authority for this provision. The
focus of this comment was disagreement with the date format chosen by
FDA and the compliance date for this provision, both of which have been
modified as detailed in this preamble.
    FDA disagrees that the FD&C Act does not provide legal authority
for Sec.  801.18. Under section 502(a) of the FD&C Act, a device is
misbranded if its labeling, which includes its label, is false or
misleading. As discussed in this preamble and the preamble to the
proposed rule, the variety of inconsistent date formats currently in
use can be confusing and misleading to device users. Many comments
agreed with FDA that requiring a uniform date format for all device
labels that is consistent with international standards should, in time,
eliminate any such confusion or misunderstanding, ensuring that the
label is not misleading to users. To the extent dates are required to
appear on the label, for example under a premarket approval (PMA)
order, section 502(c) of the FD&C Act requires that they be in such
terms as to render them likely to be understood by the ordinary
individual under customary conditions of purchase and use. Requiring a
uniform format will, in time, ensure that dates on labels intended to
be brought to the attention of users will be likely to be correctly
understood by them. In addition, section 701(a) of the FD&C Act
provides authority for FDA to issue Sec.  801.18.

E. General Exceptions from the Requirement for the Label of a Device To
Bear a Unique Device Identifier--Broad Comments Concerning Proposed
Sec.  801.30

    We received comments that expressed broad support for the
exceptions provided by proposed Sec.  801.30, and comments that
expressed broad opposition to the exceptions provided by proposed Sec.
801.30. Comments that expressed broad opposition included comments that
recommended all exceptions from UDI requirements should be on a case-
by-case basis, and comments that recommended that all of the exceptions
provided by Sec.  801.30 should be eliminated. Comments that expressed
broad support included comments to the effect that the proposed
exceptions are ``appropriate'' or ``not inappropriate,'' and a comment
that FDA should not implement any UDI requirement that creates a burden
that is not offset by corresponding value.
    FDA disagrees with the comments that suggest we should not provide
any categorical exceptions. We agree that the UDI rule should take into
account both its benefits and its costs. Similarly, we do not agree
that it would be best to rely entirely on case-by-case exceptions. A
case-by-case approach alone would be far more burdensome than providing
carefully crafted categorical exceptions,

and would be more likely to result in regulatory inconsistencies and
confusion that would hamper the objectives of the UDI system. However,
as described in this document, we made certain changes to the
exceptions in response to comments.

F. General Exceptions From the Requirement for the Label of a Device To
Bear a Unique Device Identifier--Exception for a Device, Other Than a
Prescription Device, That Is Made Available for Purchase at a Retail
Establishment, Including Such a Device Delivered Directly to a
Hospital, Ambulatory Surgical Center, Nursing Home, Outpatient
Treatment Facility, or Other Health Care Facility. Proposed Sec.
801.30(a)(1)

    FDA received many comments (approximately 35) on this proposed
exception. Roughly half of these comments requested or suggested a
clarification of some aspect of the exception. For example, comments
requested clarification concerning the meaning of ``retail
establishment,'' and whether the exception would apply to devices sold
through any retail channel, including online, and ``not simply those
sold in brick-and-mortar-type stores.'' Other comments suggested FDA
needed to clarify whether the exception would be available for a device
that is available for purchase at a retail establishment when that
device is sold directly to a hospital or physician. Some comments
supported the exception as proposed. For example, a comment stated,
``applying a UDI on each individual device [sold at retail and labeled
with a UPC] would not improve identification of devices . . . and would
amount to an unnecessary burden and cost.'' Another comment stated,
``Providing an exception for non-prescription devices sold at retail is
both wise and appropriate.'' Other comments opposed the exception as
proposed. For example, a comment stated that this exception would be
``ill-advised'' and recommended that these devices ``should be subject
to UDI requirements, but . . . their UPC codes should be deemed to be
the UDI. . . . In particular, we believe it is essential that labelers
of the affected retail products be required to submit UPC data to the
GUDID.'' Another comment recommended that the proposed exception should
not be available for devices that ``may have a significant impact on
patient health.''
    FDA believes the comments criticizing the proposed exception are
persuasive in that the availability of a device for purchase in retail
establishments has little relationship to the potential for risk of the
device. Indeed, devices available at retail include moderate and even
high risk devices such as automatic external defibrillators. Further,
devices sold through retail channels may have unusually broad
distribution resulting in correspondingly broad impact when the device
is defective and needs to be recalled. Accordingly, we are limiting the
proposed exception to provide, in Sec.  801.40(d), that a class I
device that bears a UPC on its label and device packages is deemed to
meet all UDI labeling requirements and that the UPC will serve as the
UDI required by Sec.  801.20. This excepts a class I device with a UPC
on its label and packages from UDI labeling requirements regardless of
to whom or through what channels it is sold. Such a device will be
subject to GUDID reporting requirements. We note that the lowest risk
devices available for sale at retail establishments will in any case be
excepted from UDI requirements by virtue of Sec.  801.30(a)(2).

G. General Exceptions From the Requirement for the Label of a Device To
Bear a Unique Device Identifier--Exception for Existing Inventories of
Finished Devices That Have Been Labeled Prior to the Applicable
Compliance Date--Final Sec.  801.30(a)(1)

    We received several comments (approximately 22) requesting
clarification concerning how the rule will apply to devices that were
manufactured prior to the applicable compliance date of the rule, but
which have not yet been sold to a hospital or other purchaser. For
example, a comment recommended, ``the implementation effective date
[meaning compliance date] should be tied to the date of manufacture
rather than date of distribution.'' Another comment also recommended
that the date of manufacture should be used ``to determine compliance
with the UDI requirements'' and stated this was the approach FDA used
in implementing FDA's final rule, ``Bar Code Label Requirements for
Human Drug Products and Biological Products'' (69 FR 9120; February 26,
2004). These comments were concerned that applying UDI labeling
requirements to finished devices that have already been labeled and
ready for delivery to a purchaser would require costly relabeling, and
would add to the burdens required to implement the rule's requirements.
    FDA agrees with these comments and recognizes the precedent set by
the earlier bar code label rule. Section 801.30(a)(1) of the final rule
provides an exception for a ``finished device manufactured and labeled
prior to the compliance date that applies'' to the device, but this
exception ``expires with regard to a particular device 3 years after
the compliance date that applies'' to the device. We believe that 3
years after the compliance date, which provides (depending on the
compliance date that applies to a particular device) for a total lead
time of 4 to 8 years from now, is sufficient time to exhaust existing
inventories of finished devices that have been labeled prior to the
applicable compliance date. This exception would be available for
devices held in inventory by a labeler; it would also be available for
devices consigned to a hospital or other potential purchaser and held
in inventory by the potential purchaser, but which have not yet been
sold to that potential purchaser. If a device has not yet been labeled,
this exception will not be available. Similarly, if any actions remain
to be completed before the device is considered a finished device, this
exception will not be available.
    FDA recognizes that there may be rare and unusual circumstances
where the limited period provided by this exception might be
problematic. For example, it may not be possible to relabel a
particular cryopreserved HCT/P regulated as a device held in inventory
longer than 3 years to add a UDI without damaging the HCT/P. In such
rare and unusual circumstances, FDA may exercise enforcement discretion
to permit continued distribution of a device, particularly if a device
shortage would be likely if we rigorously enforced the UDI labeling
requirements upon expiration of the exception period. Any manufacturers
who are currently aware of the need for a longer period of time than is
afforded by this rule to deplete existing inventory are encouraged to
contact FDA.

H. General Exceptions From the Requirement for the Label of a Device To
Bear a Unique Device Identifier--Exception for Class I Devices That FDA
Has Exempted From Good Manufacturing Practices--Sec.  801.30(a)(2)

    FDA received several comments (approximately 18) on this proposed
exception. One comment recommended that FDA limit the number of devices
that are exempt from UDI requirements. Nearly all of the remaining
comments supported the proposed exception and most also recommended
expansion of the proposed exception to all class I devices.
    FDA does not agree that this exception should be extended to all
class I devices. Class I devices, which constitute the majority of
medical

devices, play important functions in the health care system and in the
lives of patients and consumers. Class I devices are frequently subject
to adverse events and recalls, and without UDI the resolution of these
issues would be impeded. If all class I devices were excepted, the
objectives of the UDI system would be seriously compromised. We have,
however, amended this exception to clarify that it is available even
when a good manufacturing practice (GMP) exemption includes a
requirement for continued recordkeeping under Sec. Sec.  820.180 and
820.198.

I. General Exceptions From the Requirement for the Label of a Device To
Bear a Unique Device Identifier--Exception for Individual Single-Use
Devices, All of a Single Version or Model, That Are Distributed
Together in a Single Device Package--Sec.  801.30(a)(3)

    FDA received several comments (approximately 22) on this proposed
exception. FD&C Act section 201(ll)(1) (21 U.S.C. 321(ll)(1)) defines
``single-use device'' to mean any device that is intended for one use,
or on a single patient during a single procedure. One comment
recommended that all categorical exceptions, whether for single-use
devices, class I devices, or otherwise, should be avoided, and that
exceptions should be considered on a case-by-case basis. Seven comments
supported the proposed exception (one of these comments conditioned its
support on an assumption that MRI compatibility would not be a
concern). Thirteen comments recommended expanding the exception--four
comments suggested the exception be extended to all class I devices
(one of these suggested that if there is a category of class I devices
that warrants inclusion in the UDI system, then only that category
should be subject to UDI requirements and all other class I devices
should be exempted); seven comments suggested the exception be extended
to class II single-use devices; and two comments suggested the
exception should be extended to all single-use devices.
    FDA agrees it is appropriate to extend the exception to all classes
of devices, except implants, and the final rule does so.
    One comment requested clarification concerning how this exception
would apply to reprocessed single-use devices. With respect to a
single-use device, the term ``reprocessed'' means that the device has
been subjected to additional processing or manufacturing after use on a
patient for the purpose of rendering the device fit for an additional
use on a patient. See FD&C Act section 201(ll)(2) (21 U.S.C.
321(ll)(2).
    FDA sees no reason why a reprocessed SUD that meets the other
criteria for this exception should be excluded from the scope of the
exception.

J. General Exceptions From the Requirement for the Label of a Device To
Bear a Unique Device Identifier--Exception for a Custom Device Within
the Meaning of Sec.  812.3(b)-Sec.  801.30(a)(5)

    FDA received approximately four comments on this proposed
exception. One comment opposed this exception. Three comments
recommended this exception be extended to specific devices: Cranial
remolding orthoses, prescription eyewear, and contact lenses.
    These are types of devices and do not categorically qualify as
custom devices within the meaning of Sec.  812.3(b). We note that
single-use contact lenses, however, would be subject to the exemption
from the need to be individually labeled with a UDI under Sec.
801.30(a)(3). Concerning the other devices, FDA does not agree that
they should generally be excepted from UDI. In particular, FDA intends
the custom use exception of the final rule to be available only for
devices within the meaning of Sec.  812.3(b), and we have adopted
proposed Sec.  801.30(a)(5) without any change.

K. General Exceptions From the Requirement for the Label of a Device To
Bear a Unique Device Identifier--Exception for a Device Intended for
Export from the United States--Sec.  801.30(a)(8)

    FDA received two comments on this proposed exception. One comment
opposed the exception, viewing it as inconsistent with a ``truly
harmonized global device identification system.'' The other comment
recommended that class I single-use devices intended for export should
bear a UDI.
    FDA does not agree with either comment. There is no assurance that
a UDI that meets U.S. regulatory requirements would meet the
requirements of the nation to which a device is exported, and it is
possible that U.S. UDI requirements conflict with the requirements of
the nation to which a device is exported. For these reasons, FDA has
not accepted the recommendation of either comment, and we have adopted
proposed Sec.  801.30(a)(8) without any change.

L. General Exceptions From the Requirement for the Label of a Device To
Bear a Unique Device Identifier--Exception for a Device Packaged Within
the Immediate Container of a Combination Product or Convenience Kit--
Similar Requirements Proposed at Sec.  801.25; Revised Requirements at
Sec.  801.30(a)(11)

    Proposed Sec.  801.25 was titled, ``Unique device identifiers for
combination products, device constituent parts of a combination
product, and devices packaged in a convenience kit.'' Section 801.25
would have required the label of every combination product with a
device constituent and the label of each device constituent part of a
combination product to bear a UDI (with one narrow exception), and
would have required the label of every convenience kit and the label of
every device included in a convenience kit to bear a UDI. FDA received
many comments (approximately 70) concerning proposed Sec.  801.25.
These comments addressed a wide variety of concerns. For example, one
comment stated that the law does not require UDIs for combination
products, and that FDA therefore has ``full latitude'' in adapting UDI
to combination products. Some comments suggested a single UDI would be
sufficient for a combination product or a convenience kit, while other
comments stated it was prudent to require a UDI for both a combination
product and its device constituent parts. A comment suggested that FDA
should require a UDI on any combination product with a device
constituent part, regardless of its primary mode of action, while other
comments stated it is ``. . . NOT . . . appropriate to require each
device constituent part of [a] combination product to bear its own UDI
when the primary mode of action is not that of a device'' or suggested
combination products should be labeled with a UDI or an NDC according
to the primary mode of action of the product. Some comments wanted to
introduce additional nuances, such as requiring a UDI for the device
constituents of combination products only if ``they are already labeled
and packaged individually'' and another comment expressed the view that
any device constituent that ``may be used more than once (whether or
not intended for a single use)'' should be labeled with a UDI. One
comment recommended that the final rule should ``remove all references
to convenience kits. . . . [T]hey are very difficult to define,'' while
another comment recommended, ``FDA should require all devices in a
convenience kit to be labeled.''

    These and other comments convinced FDA that we need to simplify our
requirements regarding combination products and convenience kits. The
final rule provides a much simpler approach by removing proposed Sec.
801.25 and providing two new exceptions--
     Section 801.30(a)(11) provides that if a device is
packaged within the immediate container of a combination product or
convenience kit, the label of that device will not be required to bear
a UDI, provided that the label of the combination product or
convenience kit bears a UDI.
     Section 801.30(b) addresses situations where a combination
product properly bears an NDC number. The NDC database is a system
that, while different from the GUDID, permits tracking and
identification. Crafting this exception for products with an NDC number
avoids potentially redundant requirements. Section 801.30(b)(1) makes
clear that a combination product that properly bears an NDC number on
its label is not required to bear a UDI. As provided in Sec.
801.30(b)(2), the device constituent of a combination product described
by Sec.  3.2(e)(1) (such a product is often informally referred to as a
``single-entity'' combination product) that properly bears an NDC
number on its label is not subject to UDI labeling requirements.
Section 801.30(b)(3) makes clear that the device constituent of a
combination product described by Sec.  3.2(e)(2) (such a product is
often informally referred to as ``co-packaged'' combination product)
that properly bears an NDC number on its label must also bear a UDI on
its label, unless it is exempt under Sec.  801.30(a)(11).
    We believe this simplified approach is far more likely to be
understood and correctly applied and minimizes the changes labelers
need to make to current practices to be in compliance with the rule.

M. Medical Procedure Kits and Trays

    We received comments that were concerned with how UDI requirements
would apply to medical procedure kits and trays. A medical procedure
kit typically consists of one or more medical devices, packaged
together with one or more combination products, drugs, or biologics, to
facilitate a single surgical or medical procedure. The medical
procedure kit is typically packaged upon or within a medical procedure
tray and is packaged so as to maintain sterility or to facilitate
sterilization. The devices within a medical procedure kit are not
necessarily individually packaged, so as to be ready to use immediately
upon opening the medical procedure kit. A medical procedure tray is a
tray or other container upon or within which the components of a
medical procedure kit are arranged to facilitate a surgical or medical
procedure. Orthopedic procedure kits are a well-known example of a
medical procedure kit. These comments were primarily concerned that the
rule would require changes in the way medical procedure kits are
assembled and packaged, which could interfere with sterilization
processes and the use of the medical procedure kit.
    A medical procedure kit is either a convenience kit, if it contains
only medical devices, or a combination product, if it contains both a
device and a drug or biologic. The final rule excepts a device packaged
within the immediate container of any convenience kit or within the
immediate container of a combination product from bearing a UDI on its
label provided, as long as the kit or combination product is labeled
with a UDI in accordance with Sec.  801.30(a)(11). Where a combination
product properly bears an NDC and does not bear a UDI on its label, the
device constituent part must bear a UDI on its label. We believe this
approach addresses the concerns raised regarding medical procedure
kits.

N. General Exceptions From the Requirement for the Label of a Device To
Bear a Unique Device Identifier--Exception for a Device Held by the
Strategic National Stockpile and Granted an Exception or Alternative
Under Sec.  801.128(f)(2)-Sec.  801.30(a)(9)

    FDA received two comments that opposed this exception, which would
provide the Strategic National Stockpile (SNS) the same latitude with
regard to UDI labeling as is provided for other labeling requirements.
The commenters believe that proper SNS management requires expiration
dates on devices and the removal of recalled devices.
    FDA declines to remove this exception, which runs parallel with
other exceptions or alternatives granted under Sec.  801.128(f). The
UDI final rule does not require the use of expiration dates or the
removal of recalled devices. By the same token, the Sec.  801.30(a)(9)
exception does not restrict the use of expiration dates for SNS devices
or applicability of recalls. We believe it is highly unlikely that such
an exception or alternative will ever need to be granted, but it is
essential to provide flexibility to respond to any unforeseen set of
circumstances involving operation of the Strategic National Stockpile.

O. General Exceptions From the Requirement for the Label of a Device To
Bear a Unique Device Identifier. The Unique Device Identifier of a
Class I Device Is Not Required to Include a Production Identifier--
Sec.  801.30(c)

    FDA received approximately seven comments on this exception. Three
comments supported the exception or recommended expansion of the
exception. For example, a comment suggested FDA should extend the
exception to all devices sold at retail (this could include some class
II and some class III devices). Four comments recommended that
production identifiers be required for all class I devices, or at least
for certain class I devices. For example, two comments recommended that
the UDIs of electrically powered devices should include production
identifiers, and another comment recommended that production
identifiers be required for surgical instruments.
    FDA does not agree that this exception should be modified. We agree
that production identifiers are important, but we have provided this
limited exception to avoid imposing significant burdens on lower risk
devices, where the public health need for precise identification is
less urgent than for moderate- and high-risk devices. The final rule
adopts the proposed exception without any change.

P. Requests for Additional General Exceptions From the Requirement for
the Label of a Device To Bear a Unique Device Identifier

    Several comments suggested that the final rule should provide
additional exceptions to Sec.  801.30, excepting additional types of
devices from UDI labeling and GUDID reporting requirements or providing
for alternative placement of UDIs on some device labels; the following
examples illustrate the scope of these suggestions:
     A comment recommended ``HCT/Ps . . . be exempted from the
UDI Final Rule.''
     A comment suggested that analyte-specific reagents that
can, by regulation, be sold only to certain entities and which ``are
not directly used in any health care setting'' should be exempted from
UDI requirements.
     A comment suggested that an orthopedic procedure tray
should not be treated as a medical device, but as a type of shipping
container, as the contents vary with every shipment ``due to patient
needs.''
     A comment suggested that an exception should be provided
for sterile convenience kits sold with a ``standard

configuration of devices'' and that UDIs should not be required for
``non-sterile trays, such as orthopedic trays.''
     A comment suggested there should be an exception for
durable medical equipment.
     A comment requested an exception for medical and dental x-
ray film, because the film business is converting to digital media and
will be commercially obsolete in 5 years.
     A comment suggested that FDA should provide an exception
for certain devices that involve the generation, measurement, and use
of medical gases, calibration gases, and gases that might be regulated
as medical devices because, the comment states, they are low risk, have
limited space for labeling, would require multiple UDIs on assemblies,
already have traceable numbers, and it would be costly to make them
compliant.
     A comment requested an exception for class II medical
device gases and container closure systems, because, the comment
states, they are subject to Department of Transportation, ISO, and
Compressed Gas Association standards, are already traceable, have
relatively small batch size, and high cost to implement UDI relative to
the improvement afforded by UDI.
     A comment requested an exception for ``flat pack'' cases
in which rigid gas-permeable contact lenses are initially shipped by
the manufacturer, ``because they are commonly discarded in favor of
larger storage or disinfecting cases'' and consequently a ``requirement
that the flat pack bear a UDI would be pointless.''
     A comment requested an exception from UDI labeling for
diagnostic/trial contact lenses that are otherwise fully labeled, but
which are not intended for commercial sale.
     A comment requested an exception for a nurse call system
(characterized by the comment as a type of powered environmental
control system under Sec.  890.3725).
     A comment suggested that the implementation timeframe for
class III contact lenses is ``unrealistic'' and that class II and class
III contact lenses should be subject to the same implementation
timeframe.
    FDA is not providing a narrowly targeted exception for any of these
devices in the final rule for two reasons. First, the final rule
includes significant changes to Sec.  801.30, which provides certain
categorical exceptions from the requirement for the label of a device
to bear a UDI, and to other provisions that may be relevant to the
concerns expressed in the comments that request additional exceptions.
Second, the information provided by these requests and comments varied
considerably in scope and detail, and none provided sufficient
information to justify an FDA decision to except a category of devices
from any UDI requirement. FDA believes it is more appropriate for all
requests involving an exception or alternative to UDI requirements that
do not fit into the categorical exceptions of the final rule to be
evaluated through the revised process provided by Sec.  801.55 of the
final rule. Section 801.55 of the final rule builds on proposed Sec.
801.35, but has been revised and has expanded the circumstances under
which an exception from or an alternative to a UDI requirement may be
requested or granted. If after reviewing the changes made in the final
rule a person who requested an exception or alternative in a comment on
the proposed rule still believes that some type of exception or
alternative is required, we invite that person to submit a request
under Sec.  801.55, and to ensure that the request provides the
information required by Sec.  801.55(a).
    A comment suggested FDA should add an exception to make clear that
UDI requirements do not apply to a device constituent being shipped for
further processing as part of a combination product.
    FDA disagrees. Such shipments are already generally governed by
Sec.  801.150 (Medical devices; processing labeling, or repacking), and
should be evaluated under that framework.

Q. Request for Modification of Unique Device Identifier Labeling
Requirements for Devices That Have Small Labels

    Some comments suggested the rule should provide an exception from
UDI labeling requirements ``where the label is too small'' to
accommodate both human readable and AIDC information, ``provided that
the UDI appears on the next higher level of packaging.'' A similar
comment suggested that if a device with a small label is included in a
convenience kit, a UDI should be required only on the label of the
convenience kit.
    FDA believes that some of the concerns underlying these requests
have been resolved by the revisions made to Sec.  801.30, which
provides general exceptions from the requirement for the label of a
device to bear a UDI. For example, under the final rule, except for
implantable devices, we have extended to all classes the exception for
individual single-use devices, all of a single version or model, that
are distributed together in a single device package, and which are not
intended for individual commercial distribution (see Sec.
801.30(a)(3)), and a UDI is not required on the label of the device
constituents of combination products and the contents of convenience
kits as long as the label of the combination product or convenience kit
bears a UDI (see Sec.  801.30(a)(11)).
    FDA does not agree that any additional exception should be provided
in the final rule based only on the size of the device label. First,
the comments we received did not provide sufficient information to
allow FDA to establish objective criteria to guide labelers in deciding
when a device label or package would be ``small enough'' to qualify for
any exception we might provide. Second, none of the comments we
received provided sufficient information to evaluate the reach of an
exception based on size. For these reasons, we believe it is preferable
that requests for an exception or alternative to UDI requirements based
on label size be evaluated through the process provided by Sec.  801.55
of the final rule; this provision is explained in the section II.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.'' Accordingly, we are not making any special provision
concerning the labeling of small devices, and we expect the labels of
devices of all sizes to bear a UDI as required by the final rule.

R. Voluntary Labeling of a Device With a Unique Device Identifier--
Proposed Sec.  801.40; Revised Requirements at Sec.  801.35

    FDA received two comments on this provision.
    One comment stated voluntary UDI labeling will cause confusion, as
most exempt devices will already bear a UPC.
    FDA does not agree with this comment. We do not believe that any
confusion will result from such labeling, as the formats of a UPC and a
UDI will differ. The final rule permits, but does not require, a device
to bear both a UDI and a UPC.
    The other comment stated that if there are no categorical UDI
exceptions, there would be no reason to allow voluntary UDI labeling.
    Because FDA has determined that the final rule will provide a
number of categorical exceptions, as explained previously, we cannot
agree with this comment. The final rule does, however, make a change to
this provision. In paragraph (b), we have deleted language that would
have limited the use of UPCs to instances where a device ``is sold at
retail.'' We do not believe that restriction is necessary to the
objectives of the final rule, and its removal makes

clear that a class I device that bears a UPC on its label will be
deemed to meet of the requirements of Sec.  801.20(a).

S. Form of a Unique Device Identifier--Technical Requirements--Proposed
Sec.  801.45(a); Sec.  801.40(a) of the Final Rule

    FDA received many comments (approximately 25) on these
requirements. Several of these comments simply voiced agreement with
the proposal, or agreed that the requirement for an easily readable
plain-text form of the UDI is clear.
    Several comments suggested the rule should be more prescriptive.
Many of these comments suggested FDA should designate a single issuing
agency to operate the UDI system; that we should require the UDI system
to conform to standards in addition to those that are incorporated by
reference in part 830; that we should require use of one particular
form of AIDC, such as particular versions of 2D or 3D barcodes or
particular technologies to read and record those barcodes; that we
should require the system to be designed so as to be compatible with
systems used by certain other governmental agencies. Other comments
took an opposing view, and urged FDA to remain technologically neutral,
and not to require use of a particular form of AIDC; to allow the heath
care community to adapt to new technologies and process improvements;
to recognize that labelers need the greatest amount of flexibility to
handle changes in technology as they arise; and to allow flexibility in
the use of AIDC technology to encourage innovation.
    We believe that choosing a single issuing agency would limit the
health care community's ability to develop and use appropriate device
identification systems. Labelers currently use more than one system,
each of which creates a globally unique identifier, and these systems
can be used simultaneously to support different device types.
    FDA does not agree that the UDI rule should be highly prescriptive
with regards to AIDC technologies or standards. Requiring adherence to
a particular AIDC technical standard would be detrimental to innovation
concerning AIDC technologies, and would, we believe, do long-term harm
by slowing the adoption of new technologies. There is nothing in
section 519(f) of the FD&C Act that suggests FDA must, or should,
impose a highly prescriptive UDI system. FDA agrees with comments that
recommend that FDA not require the use of specific forms of AIDC or
specific AIDC technologies.
    A comment stated that permitting labelers to use a barcode or RFID
as its AIDC would force purchasers to incur increased costs in order to
read these differing forms of AIDC.
    Though this rule does not impose any requirement on the purchaser
or users of a device, we recognize the potential need for end users to
acquire different technologies to read multiple forms of AIDC
technologies. This potential concern, however, must be balanced against
the concerns discussed in this document about prescribing a single AIDC
technology, which FDA believes could also incur costs for certain
purchasers as well as for labelers. As elsewhere in this rule, we have
chosen the approach that retains flexibility for those subject to the
regulation rather than prescribing a new requirement in the absence of
a justification or uniform support.
    The final rule makes no changes to the language of proposed Sec.
801.45(a), now at Sec.  801.40(a) of the final rule.

T. Form of a Unique Device Identifier--Unique Device Identifier To
Include Device Identifier and Production Identifier--Proposed Sec.
801.45(b); Revised Requirements at Sec.  801.40(b) of the Final Rule

    FDA received a few comments (approximately four) on these
requirements.
    Three comments suggested that if HCT/Ps regulated as devices are
subject to the rule, the distinct identification code required in Sec.
1271.290(c) should be added to the list of production identifiers that
are used as part of an HCT/P's UDI.
    FDA agrees with this view, and we have added ``the distinct
identification code required by Sec.  1271.290(c) to the list of
production identifiers included in the definition of unique device
identifier (UDI). Labelers are required to report to the GUDID only the
type of production identifiers that appear on the label of the device,
and not individual production identifiers. For example, if a serial
number is provided on a device label, the labeler would have to report
that fact to the GUDID, but would not have to report each individual
serial number to FDA. Production identifiers such as distinct
identification code required by Sec.  1271.290(c) to appear on device
labels will not have to be submitted to FDA and will not be included in
the GUDID.
    One comment raised a concern about how production identifiers would
apply to laboratory-developed tests (LDTs). Another comment claimed
that LDTs are services, do not fall within the definition of ``device''
at section 201(h) of the FD&C Act, and that FDA therefore lacks
statutory authority to impose UDI requirements on LDTs.
    As this rule does not make changes to what qualifies as a
``device'' under section 201(h) of the FD&C Act, this comment is beyond
the scope of this final rule.

U. Form of a Unique Device Identifier--Proposed Symbol To Indicate the
Presence of Automatic Identification and Capture Technology--Proposed
Sec.  801.45(c); Revised Requirements at Sec.  801.40(c) of the Final
Rule

    Proposed Sec.  801.45(c) would have required a device label or
device package to bear a symbol indicating the presence of AIDC
technology whenever the AIDC ``is not evident upon visual examination
of the label or device package.'' The proposed language identified the