[Federal Register Volume 77, Number 132 (Tuesday, July 10, 2012)]
[Proposed Rules]
[Pages 40735-40778]
[FR Doc No: 2012-16621]

Vol. 77

Tuesday,

No. 132

July 10, 2012

Part III

Department of Health and Human Services

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Food and Drug Administration

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

Unique Device Identification System; Proposed Rule

Federal Register / Vol. 77 , No. 132 / Tuesday, July 10, 2012 /
Proposed Rules

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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: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to
establish a unique device identification system to implement the
requirement added to the Federal Food, Drug, and Cosmetic Act (FD&C
Act) by section 226 of the Food and Drug Administration Amendments Act
of 2007 (FDAAA), Section 226 of FDAAA amended the FD&C Act to add new
section 519(f), which directs FDA to promulgate regulations
establishing a unique device identification system for medical devices.
The system established by this rule would require the label of medical
devices and device packages to include a unique device identifier
(UDI), except where the rule provides for alternative placement of the
UDI or provides an exception for a particular device or type of device
such as devices sold over-the-counter and low risk devices. Each UDI
would have to be provided in a plain-text version and in a form that
uses automatic identification and data capture (AIDC) technology. The
UDI would also be required to be directly marked on the device itself
for certain categories of devices for which the labeling requirement
may not be sufficient, for example, those that remain in use for an
extended period of time and devices that are likely to become separated
from their labeling. The rule would require the submission of
information concerning each device to a database that FDA intends to
make public, to ensure that the UDI can be used to adequately identify
the device through its distribution and use.

DATES: Submit either electronic or written comments on the proposed
rule by November 7, 2012. Submit comments on information collection
issues under the Paperwork Reduction Act of 1995 by September 10, 2012,
(see section V, the ``Information Collection Requirements'' section of
this document). See section VII for the proposed effective date of a
final rule based on this proposed rule.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2011-
N-0090 and/or RIN No. 0910-AG31, by any of the following methods,
except that comments on information collection issues under the
Paperwork Reduction Act of 1995 (see the ``Information Collection
Requirements'' section of this document) must be submitted to the
Office of Regulatory Affairs, Office of Management and Budget (OMB) at
FAX:<PHONE_NUMBER>, or email comments to<EMAIL_ADDRESS>
Please mark your comments to the attention of the FDA desk officer and
reference this rule.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Fax:<PHONE_NUMBER>.
     Mail/Hand delivery/Courier [For paper or CD-ROM
submissions]: Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency
name, Docket No., and Regulatory Information Number (RIN) for this
rulemaking. All comments received may be posted without change to
http://www.regulations.gov, including any personal information
provided. For additional information on submitting comments, see the
``Comments'' heading of the SUPPLEMENTARY INFORMATION section of this
document
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Jay Crowley, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Avenue, Silver Spring, MD 20993,<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Executive Summary

Purpose of the Regulatory Action

    This rule is intended to 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 would reduce medical errors that result from misidentification of
a device or confusion concerning its appropriate use. The
identification system established under this rule would lead to more
accurate reporting of adverse events by making it easier to identify
the device prior to submitting a report. It would allow FDA, healthcare
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 will fulfill the statutory requirement of section 519(f)
of the FD&C Act (21 U.S.C. 360i(f)), which directs FDA to promulgate
regulations establishing a unique device identification system for
medical devices; this requirement was added to the FD&C Act by section
226 of the Food and Drug Administration Amendments Act of 2007 (FDAAA),
Public Law 110-85.
    In developing the proposed rule, FDA has been partnering with
industry to conduct pilot tests to identify potential issues and
generate feedback on the development of a UDI system. Throughout the
pilot activities, labeler organizations from the medical device
industry focused on identifying and understanding potential issues that
would arise for labelers in implementing UDI and provided that feedback
to FDA. The proposed rule reflects this industry input and the lessons
learned from these pilot activities. FDA also solicited input through
public meetings; a public workshop with stakeholders from the medical
device industry, hospitals, payors and other stakeholders; and, a
public request for information on a series of key questions related to
the development of UDIs through which FDA received extensive input from
the medical device industry and the broader healthcare community. FDA
solicits comments on the proposed rule from all interested
stakeholders, and is particularly interested in industry comment on
whether the proposed approach reflects the lessons from the pilot
activities.
    Under the proposed system, the health care community and the public
would be able to identify a device

through a UDI that will appear on the label and package of a device.
The UDI will provide a key to obtain critical information from a new
database, the Global Unique Device Identification Database (GUDID),
which will include information important to the identification of
devices. 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.
Certain devices for which the labeling requirement alone may not be
sufficient would also be directly marked with a UDI, allowing accurate
identification even when the device is no longer accompanied by its
label or package. The types of devices that would be subject to the
direct marking require are implantable devices; devices intended to be
used more than once, and which are intended to be sterilized before
each use; and stand-alone software. These types of devices have
physical characteristics, or characteristics of use, that significantly
increases the probability that the device will become separated from
its label, particularly when used over an extended period of time.
    By ensuring the adequate identification of medical devices through
distribution and use, the rule would serve several important public
health objectives--
    Reduce Medical Errors. The presence of a UDI that is linked to
device information in the GUDID database will facilitate rapid and
accurate identification of a device, thereby removing a cause of
confusion that can lead to inappropriate use of a device (e.g.,
confusion as to whether a device is packaged as sterile, or failure to
recognize that a device is the subject of a recall or enforcement
action). 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,
would allow rapid and accurate data acquisition, recording, and
retrieval. 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 requirements 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 also would require the inclusion of UDIs in adverse
event reports that are required under part 803. This would 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 and the UDI, particularly when
combined with AIDC technology, will hasten the identification of
devices that are the subject of a recall. The more rapidly a recall is
implemented and completed, the more rapidly the risks presented are
reduced and eliminated.
    Better-Focused and More Effective FDA Safety Communication. By
citing UDIs, FDA would 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.
    Provide an Easily-Accessible Source of Definitive Device
Identification Information. While not required, inclusion of device
identifiers in informational and educational materials, such as package
inserts, training materials, educational materials, and other
supplementary information, could provide a quick and useful means for
patients and health care professionals to obtain additional information
concerning a device, without having to provide that information in the
document. This could allow the document to focus on its important core
messages without the distraction of greater complexity, while a reader
who wants those additional details could use the UDI to obtain
information from the GUDID.
    Additional Benefits. FDA expects the UDI system will provide
additional benefits. For example, UDIs could be used to enhance
management of the Strategic National Stockpile, inventory management,
and the provision of high-quality medical services. UDIs will
facilitate the development of more useful electronic patient records by
allowing providers to electronically capture and record important
information concerning the use (including implantation) of a device on
a patient. UDIs could help identify similar devices in the event of a
shortage, and could help detect counterfeit devices.
    Standard Format for Dates Provided on a Device Label or Package.
The rule would also contribute to improved identification of medical
devices, and at the same time, better ensure the safe use of devices,
by requiring dates on medical device labels to conform to a standard
format--Month, Day, Year (e.g. JAN 1, 2012)--to ensure dates are
unambiguous and clearly understood by device users.
Summary of the Major Provisions of the Regulatory Action in Question
    This rule would require the label of medical devices and device
packages to include a UDI, except where the rule provides for
alternative placement of the UDI or provides an exception for a
particular device or type of device. Each UDI would have to be provided
in a plain-text version and in a form that uses AIDC technology. The
UDI would also be required to be directly marked on the device itself
for certain categories of devices, such as those that remain in use for
extended periods of time and are likely to become separated from their
labeling. The rule would require the submission of information
concerning each device to a database that FDA intends to make public,
to ensure that the UDI can be used to adequately identify the device
through its distribution and use. The FDA database would not include
patient information. The rule would also require dates on device labels
and packages to be presented in a standard format.
    The UDI system proposed by this rule builds on international
regulatory cooperation activities and existing, internationally
recognized standards relating to unique identification and data
exchange. The rule would specify

the technical requirements of a UDI, which would consist of a portion
that identifies the specific version or model of the device and the
labeler of the device (the device identifier), and a portion that more
precisely identifies the specific device by providing variable
information, such as the lot or batch, the serial number, expiration
date, or date of manufacture (the production identifier). Devices
exempted from this proposed rule include devices, other than
prescription devices, that are sold at retail establishments; this
exception also applies to such a device when delivered directly to
hospitals and other health care facilities. Also exempted are class I
devices that FDA has by regulation exempted from the good manufacturing
practice requirements of part 820 of this chapter. The production
identifier would not be required for Class I devices. The proposed rule
explains when a UDI is required and when its use must be discontinued.
The rule would require all UDIs to be issued under a system operated by
an FDA-accredited issuing agency. The rule would provide a process
through which an applicant would seek FDA accreditation. The proposed
rule specifies the information that the applicant would provide to FDA
and the criteria FDA would apply in evaluating applications. The rule
includes provision for the suspension or 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 would
be required to submit information concerning the device to FDA to
facilitate the rapid identification of the device and the labeler, and
to provide links to other FDA data. FDA will make this information
available to the public through a variety of channels, including a new
database, the GUDID.
    The rule provides for appropriate exceptions and alternatives,
ensuring that the costs and burdens are kept to a minimum.
    A final rule would become effective in stages, over a period of
seven 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.
BILLING CODE 4160-01-P

[GRAPHIC] [TIFF OMITTED] TP10JY12.008

BILLING CODE 4160-01-C

Table of Contents

I. Background
    A. Objectives of the Proposed Rule
    1. Reduce Medical Errors
    2. Simplify the Integration of Device Use Information Into Data
Systems
    3. Provide for More Rapid Identification of Medical Devices With
Adverse Events
    4. Provide for More Rapid Development of Solutions to Reported
Problems
    5. Provide for More Rapid, More Efficient Resolution of Device
Recalls
    6. Better Focused and More Effective FDA Safety Communication

    7. Provide an Easily-Accessible Source of Definitive Device
Identification Information
    8. Additional Benefits
    B. Certain Public Health Benefits of UDI Depend on the Adoption
of IT Systems by Hospitals and Other Healthcare Facilities and on
Statistical Methodologies to Interpret the Data Aggregated Using the
UDI
    C. Principles That Guided Development of the Proposed Rule
    D. Prior Consultation With the Health Care Community and
Industry
II. Description of the Proposed Rule
    A. Overview
    B. UDI Labeling Requirements (Part 801)
    1. Definitions
    2. When would the requirement for UDI labeling go into effect,
and where would the UDI have to appear?
    3. How would UDI labeling requirements apply to a combination
product and a device constituent part of a combination product?
    4. How would UDI labeling requirements apply to a convenience
kit?
    5. Exceptions From, and Alternatives to, UDI Labeling
Requirements
    6. May a device that is exempt from UDI labeling requirements
nevertheless be labeled with a UDI?
    7. How would a UDI have to appear on a device label and on a
device package?
    8. When would a device have to be directly marked with a UDI?
    9. After the requirement for UDI labeling goes into effect, may
I continue to identify my device with the national health-related
item code (NHRIC) or national drug code (NDC) number assigned to it?
    10. Formatting of Dates Provided on Medical Device Labels
    C. Requirements Relating to Issuing Agencies and Submission of
Data to the Global Unique Device Identification Database (Part 830)
    1. Definitions
    2. What would be the requirements for the composition and
issuance of a valid unique device identifier?
    3. Use and Discontinuation of a Device Identifier
    4. What changes would require a new device identifier?
    5. How would FDA accredit an issuing agency?
    6. What would be the responsibilities of an FDA-accredited
issuing agency?
    7. How would an issuing agency relinquish its accreditation, and
how would FDA suspend or revoke an issuing agency's accreditation?
    8. When would FDA act as an issuing agency?
    9. What devices would be subject to GUDID data submission
requirements?
    10. Would FDA ever reject data submitted to the GUDID or remove
data from the GUDID?
    11. What device identification data would I have to submit to
the GUDID?
    12. How would I have to submit device identification data to the
GUDID?
    13. When would I have to submit device identification data to
the GUDID?
    14. Would I be permitted to submit information to the GUDID that
is not required by FDA?
    15. What records would a labeler be required to maintain
concerning its UDIs?
    16. Who would have access to the information I submit to the
GUDID?
    D. Conforming Amendments
III. Legal Authority for the Proposed Rule
IV. Analysis of Impacts
    A. Summary of Costs
    1. Costs to Domestic Labelers
    2. Costs to Issuing Agencies
    3. Costs to FDA to Establish and Maintain the GUDID
    4. Cost to Foreign Labelers
    5. Uncertainty
    6. Alternatives
    B. Summary of Regulatory Flexibility Analysis
    C. Summary of Benefits
V. Information Collection Requirements
    A. Reporting Requirements
    B. Recordkeeping Requirements
    C. Total Annual Cost Burden
VI. Environmental Impact
VII. Proposed Effective Date
VIII. Federalism
IX. Request for Comments
    A. Submission of Comments
    B. Specific Questions
X. References

I. Background

A. Objectives of the Proposed Rule

    This rule is intended to substantially reduce existing obstacles to
the adequate identification of medical devices used in the United
States. By providing the means to rapidly and definitively identify a
device and key attributes that affect its safe and effective use, the
rule would reduce medical errors that result from misidentification of
a device or confusion concerning its appropriate use. The
identification system established under this rule would lead to more
accurate reporting of adverse events by making it easier to identify
the particular device involved prior to submitting a report. It would
also allow FDA, healthcare 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, narrowly-focused,
corrective action.
    The rule will fulfill a statutory directive to establish a unique
device identification system. Section 226 of FDAAA amended the FD&C Act
to add new section 519(f), which directs FDA to promulgate regulations
establishing a unique device identification system for medical devices:
``Unique Device Identification System. The Secretary shall promulgate
regulations establishing a unique device identification system for
medical devices requiring the label of devices to bear a unique
identifier, unless the Secretary requires an alternative placement or
provides an exception for a particular device or type of device. The
unique identifier shall adequately identify the device through
distribution and use, and may include information on the lot or serial
number.''
    Under the system that would be established by this proposed rule,
two tools would be used together to identify a device: A UDI on the
label and packaging of a device (represented both in plain text and
through automatic identification and capture technology), and a new
database, the GUDID, containing device identification information for
each UDI. Certain devices, such as those that remain in use for
extended periods of time and are likely to become separated from their
labeling, would also be directly marked with a UDI, allowing accurate
identification even when the device is no longer accompanied by its
label or package. The principles behind the rule's requirements and
exceptions regarding UDI labeling and the GUDID are discussed in more
detail in section I.B of this document.
    By requiring adequate identification of medical devices through
distribution and use, the rule would serve several important public
health objectives--
1. Reduce Medical Errors
    Device-related medical errors are a serious problem. The presence
of a UDI that is linked to identifying information in the GUDID
database will facilitate rapid and accurate identification of a device,
thereby removing a cause of confusion that can lead to inappropriate
use of a device (e.g., confusing a sterile version or model with a
version or model that is not sterile and which requires sterilization
prior to use, or failing to recognize that a particular device is the
subject of a recall or enforcement action). The presence of AIDC
technology as part of a UDI would make it possible to ``scan'' a device
at a patient's bedside and rapidly compare the device attributes
reported to the GUDID with the medical order and the patient's history,
thereby improving the accuracy of device use and providing greater
assurance that a device is appropriate for the patient.
    Providing a single, authoritative source of information--the
GUDID--to facilitate the unambiguous identification of medical devices
used in the United States.
    The proposed system would allow anyone to use a device's UDI to
look up identifying information in the GUDID

concerning the device, including: The FDA premarket submission number
of the device; the proprietary, trade, or brand name of the device; any
version or model number or similar reference; the Global Medical Device
Nomenclature (GMDN) generic descriptor for the device; if the device is
available in more than one size, the size of the particular version or
model, together with the unit of measure; the total number of devices
in the package; and an email address or telephone number for a contact
who can provide additional information to FDA. Together, this
information will permit positive identification of the device and
prevent confusion with any similar 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.
    Ensuring the accurate identification of certain devices, even when
the device is separated from its label and package.
    The rule would require some devices to be directly marked with a
UDI, so that it will always be possible to positively identify the
device, regardless of how long the device remains in use. These
devices, by their intended or customary use, are typically separated
from the labeling that accompanies delivery of the device to users:
     An implantable device;
     A device that is intended for more than one use and to be
sterilized before each use; and
     Stand-alone software.
    These devices involve unique risks to patients, and consequently it
is particularly important to ensure the adequate identification of such
devices throughout the entire product life cycle. For example, a device
that is intended for more than one use, but which must be sterilized
before each use, might be used over several years; during that time,
the device package, with its label and any package insert, might be
lost, leaving the user of the device uncertain as to whether the device
needs to be sterilized, or just given a routine cleaning, and if
sterilization is required, what type of sterilization process should be
employed. The same is true for implanted devices and stand-alone
software--loss of the device package and accompanying labeling can
leave the user uncertain as to how to use the device, how to monitor
its performance, or what actions should be taken in particular
circumstances.
    Providing rapid and continuous access to key information relating
to the device.
    FDA intends to provide Internet access to all data in the GUDID.
Furthermore, once data concerning a device has been submitted to the
GUDID, it will remain available long after production and marketing of
the device has ceased. The GUDID will include information important to
the identification of the device, but will not include patient
information.
2. Simplify the Integration of Device Use Information Into Data Systems
    UDIs, particularly when provided through AIDC technology, would
allow rapid and accurate data acquisition, recording, and retrieval.
The use of UDIs in patient records, particularly electronic patient
records, would help avoid confusion among similar devices during an
extended treatment period and where more than one health care provider
is involved in the administration of a course of treatment. 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
requirements of the health care professional who ordered the use of the
device.
3. 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 proposed UDI system would
make this possible. From 2005 through 2009, FDA received an average of
more than 492,000 adverse event reports involving devices each year.
During this 5-year period, more than 17,700 reports involved a death,
and more than 283,000 reports involved an injury.
    Because reports come from multiple sources--manufacturers, device
user facilities, importers, and voluntary reports from physicians and
other concerned individuals--we often receive more than one report of a
particular death or injury. Reviewing a significant number of reports,
seeking essential missing information, and resolving inconsistencies
among reports are major challenges, particularly when trying to
identify recurring problems involving a particular device. Although we
do not have precise statistics, many initial reports do not provide a
precise identification of the specific device the report concerns and
require extensive FDA follow-up to identify the specific device
involved. The inclusion of UDIs in adverse event reports would lead to
greater accuracy in reporting, and eliminate uncertainty concerning the
identity of devices that are the subject of reports.
4. Provide for More Rapid Development of Solutions to Reported Problems
    The inclusion of UDIs in adverse event reports would allow
manufacturers and FDA to more rapidly review and analyze reports and
identify the particular device at issue. This would permit more rapid
isolation and identification of the underlying problems, and
development of an appropriate solution to a particular concern. UDIs
would also allow FDA, manufacturers, and the healthcare community to
more accurately target safety alerts, recalls, and other corrective
actions on the specific devices that are of concern. UDIs, particularly
when provided using AIDC technology, would allow device user facilities
and health care professionals to identify those devices more rapidly
and with greater assurance, and prevent further patient exposure. At
the same time, devices not implicated by the problem would be less
likely to be ``swept up'' in an over-broad attempt to remove
potentially hazardous devices.
5. Provide for More Rapid, More Efficient Resolution of Device Recalls
    Currently, locating all devices subject to a recall is a time- and
labor-intensive process. Manufacturers, distributors, and healthcare
facilities often do not know how many recalled devices they have in
stock, do not know exactly where those devices are located, and are
sometimes uncertain which of several similar devices is the subject of
a recall. Consequently, delays in identifying recalled devices can
result in the continued use of those devices on patients in a variety
of settings (e.g., hospitals, long-term care facilities, homecare
environments) and involves an increased risk for patient harm. A device
labeled with a UDI can be identified more rapidly and with greater
precision than a device that does not bear a UDI. The use of AIDC
technology, such as a bar code, would allow increased use of automation
to speed efforts to identify specific devices that are the subject of a
recall. The more rapidly a recall is implemented and completed, the
more rapidly the risks presented are reduced and eliminated.
    A class 1 recall is the most serious type of recall, and involves a
situation where there is a reasonable probability that use of the
device will cause serious injury or death. It is particularly
important, therefore, that a class 1 recall be completed as rapidly as
possible. The absence of a system that allows rapid

and reliable identification of the particular devices that are being
recalled means hospitals and health care professionals have to rely on
a variety of identification systems and examine a variety of attributes
to identify a recalled device. A class 1 recall may direct that a
device be returned to the manufacturer for exchange or refund, be
destroyed, or be subjected to some other corrective action, such as a
software upgrade. Any confusion or lack of complete clarity in
identifying the device will undermine the effectiveness of the recall.
Therefore, each recall attempts to identify the device as precisely as
possible, but the great variation in devices and the terms used to
describe them can make it difficult to describe a device with complete
clarity. Here are some of the descriptors manufacturers used to
identify specific devices subject to class 1 recalls during 2008 and
2009:

    Table 2--Examples of Descriptors Used To Identify Devices Subject to Class 1 Recalls During 2008 and 2009
----------------------------------------------------------------------------------------------------------------
                 Descriptor                              Example of a recall that used the descriptor
----------------------------------------------------------------------------------------------------------------
Catalog number..............................  Pointe Scientific, Inc., Liquid Glucose Hexokinase Reagent
                                               (October 19, 2009).
Lot number..................................  Covidien Pedi-Cap End-Tidal CO2 Detector (July 17, 2009).
Material Number.............................  Boston Scientific NexStent Monorail, NexStent Carotid Stent and
                                               Monorail Delivery System (June 6, 2008).
Model number................................  Baxter Colleague Single and Triple Channel Volumetric Infusion
                                               Pumps (January 23, 2009).
Part number.................................  Synthes USA, Ti Synex II Vertebral Body Replacement (September 14,
                                               2009).
``Product code''............................  Smiths Medical ASD, Inc., Portex Uncuffed Pediatric[dash]Sized
                                               Tracheal Tubes (August 25, 2009).
                                                 Note: The ``product code'' used here is a code developed by
                                                  Smiths Medical; it is not the product code used by FDA.
Product number..............................  Physio Control, Inc. LifePak CR Plus Automated External
                                               Defibrillators (August 29, 2008).
Serial number...............................  ZOLL Medical Corporation, ZOLL AED Plus Defibrillator (February
                                               12, 2009).
Universal Product Code (UPC)................  Luv N' Care Gel-Filled Teethers--``Nuby,'' ``Cottontails,'' and
                                               ``Playschool'' (July 17, 2009).
----------------------------------------------------------------------------------------------------------------

    Often, a recall must cite more than one descriptor to identify the
specific devices subject to the recall. For example, a September 22,
2009, class 1 recall of the Penumbra, Inc., Neuron 6F 070 Delivery
Catheter required reference to both the product catalog number and the
lot number to determine whether a particular catheter was subject to
the recall, and a June 17, 2009, class 1 recall of Abbott Vascular-
Cardiac Therapies/Guidant Corp. POWERSAIL Coronary Dilatation Catheters
referred to product designation, product number, lot number, and
expiration date. Recalls would be expedited and simplified if a single
descriptor, such as the proposed UDI, could serve to adequately
identify all devices.
    There is no uniformity in the placement or formatting of the
descriptors presently used to identify devices, and no assurance that
different companies are using a given term in the same way. The
inconsistency in methods used to identify a recalled device complicates
efforts to identify such devices that remain in possession of a
patient, physician, or in a hospital's inventory and to complete the
remedial action that would mitigate or eliminate the risk of further
harm. These problems would be significantly reduced by the presence of
UDIs on the labels and packaging of devices and the inclusion of UDIs
in recall notification information. The inclusion of AIDC technology,
such as a bar code or a RFID tag, would permit inventories to be
checked more rapidly and would result in the more accurate detection
and removal of recalled devices.
6. Better-Focused and More Effective FDA Safety Communication
    By citing a device identifier, or a range of UDIs, FDA would be
able to more precisely focus a safety alert, public health
notification, or other communication on the particular device that is
the subject of the alert, eliminating confusion with similar devices.
Health care professionals and patients would be able to take responsive
action more rapidly, and users of similar devices that are not the
subject of the safety alert would not be faced with the uncertainty of
not knowing whether they have been exposed to, or are affected by, a
problem or risk.
7. Provide an Easily-Accessible Source of Definitive Device
Identification Information
    While not required, inclusion of device identifiers in
informational materials, such as package inserts, could provide a quick
and useful means for patients and health care professionals to obtain
additional information concerning a device, without having to provide
that information in the document. This could allow the document to
focus on its important core messages without the distraction of greater
complexity, while a reader who wants those additional details could use
the UDI to obtain information from the GUDID.
8. Additional Benefits
    FDA has concluded that a UDI system has the potential to provide
additional benefits. For example, we expect UDIs could be used by other
Federal agencies, such as the Centers for Medicare and Medicaid
Services, the National Institutes of Health, the Centers for Disease
Control and Prevention, the Department of Defense, the Department of
Homeland Security, and the Department of Veterans Affairs, for a wide
variety of purposes, ranging from management of the Strategic National
Stockpile, inventory management, and the provision of high-quality
medical services. Other benefits include facilitating the development
of more useful electronic patient records by allowing providers to
electronically capture and record important information concerning the
use of a device on a patient. UDIs could help identify similar devices
in the event of a shortage, and could reduce the potential for injury
from counterfeit devices by offering a better way to detect a
counterfeit product and remove it from the market.
    The UDI system would provide a basic infrastructural element, which
would allow unambiguous identification of medical devices throughout
their lifecycle and would provide the foundation for a host of
benefits. These may include improved device traceability, improved
postmarket surveillance, and better security of devices through more
effective detection and removal of counterfeit devices, and other

improvements that support FDA's public health mission.
    Through our work with the Global Harmonization Task Force (GHTF)
and foreign regulatory partners, we envision that the UDI system would
support global public health initiatives with which FDA is concerned,
including more efficient and effective cross-border identification of
devices, adverse event reporting and postmarket surveillance, and would
improve our ability to communicate and respond to issues and concerns
about devices used not only in the United States, but in other nations
as well.

B. Certain Public Health Benefits of UDI Depend on the Adoption of IT
Systems by Hospitals and Other Healthcare Facilities and on Statistical
Methodologies to Interpret the Data Aggregated Using the UDI

    The full benefits of UDI require that hospitals and other
healthcare facilities concurrently adopt information technology (IT) to
fully realize the enhanced ability to identify devices throughout
distribution and use. In order to realize its full potential benefits,
UDI users must be able to store UDI information in various
administrative, clinical and payment information systems, including
EHRs. Though many such systems exist today, changes will need to be
made in the systems to accommodate UDI.
    The use of electronic health technology to reduce medical errors in
healthcare facilities would require the use of scanners (many of which
are already in place) and standard operating procedures for using newly
developed systems that link critical patient information (such as latex
sensitivity) with specific medical device information. Hospitals and
other health-care facilities will choose to make investments in the new
technology and methods if they expect it to be a cost-effective method
to reduce errors and improve patient safety involving medical devices.
    Putting a standardized unique device identifier on a device label
is one step in creating systems that could reduce device related
medical errors. The proposed rule would create a platform that would
enhance the value of the new electronic health technologies and thereby
encourage their development. But the proposed rule does not require
hospitals and other health care facilities to make these changes.

C. Principles That Guided Development of the Proposed Rule

    In developing our proposed system for identification of devices,
FDA first developed several general objectives, or principles, that we
then applied throughout the drafting of our proposed rule. Each of
these principles is identified in this section I.B, with a brief
discussion of how they are resolved in the proposed rule.
    The UDI system should generally include all classes of devices,
with appropriate exceptions.
    The healthcare community needs to identify a wide range of medical
devices in every medical specialty. When fully phased-in, the rule will
apply to all three device classes; however, we are proposing to exempt
class I devices from production identifiers and proposing full
exceptions from UDI labeling and data reporting for certain very low
risk devices and other categories of devices; see proposed Sec. Sec.
801.30, 801.35, and 801.128(f). Although we are not aware of compelling
reasons for other exemptions based on the device class or medical
specialty, for example, we seek comments on this issue.
    The UDI system should be based on existing, broadly-accepted
standards.
    Basing the UDI system on existing, accepted standards ensures that
all UDIs will be unique, broadly compatible, and broadly accepted for
use by the U.S. healthcare community and in international commerce. By
incorporating these existing standards into our proposed system, we
avoid the confusion, inconsistency, and inefficiency that would result
if every labeler created their own device identifiers without regard
for the needs of the healthcare community. Therefore, the UDI system we
are proposing would incorporate by reference four international
standards: International Organization for Standardization/International
Electrotechnical Commission (ISO/IEC) 646:1991, Information
technology--ISO 7-bit coded character set for information interchange;
ISO/IEC 15459-4:2006(E), Information technology--Unique identifiers--
Part 2: Registration procedures; ISO/IEC 15459-4:2008, Information
technology--Unique identifiers--Part 4: Individual items; and ISO/IEC
15459-6:2007, Information technology--Part 6: Unique identifier for
product groupings. See proposed Sec.  830.10. In addition, all widely-
used AIDC technologies--e.g., bar codes, RFID tags, and near-field
communication are based on established, broadly-supported standards.
(Ref. 1) A multiplicity of nonstandardized systems would impose
excessive costs on device user facilities and others, would provide no
assurance that identifiers would be unique, would run counter to
efforts to achieve international harmonization with regard to the
identification of devices, and would greatly complicate FDA efforts to
identify and resolve adverse events and other problems involving
devices.
    The UDI system should recognize that the private sector has already
implemented device identification systems, and, where possible, the
rule should not require significant alteration of those systems.
    FDA is aware of two existing device identification systems that are
based on the ISO/IEC standards discussed in the preceding paragraph.
The International not-for-profit association known as ``GS1'' operates
a system that uses a Global Trade Identification Number (GTIN) to
identify a device; GS1 also operates the Universal Product Code (UPC)
system that is used to identify most items sold by retail
establishments in the United States. (Ref. 2) The Health Industry
Business Communications Council (HIBCC) operates a system that encodes
an identifier in a Health Industry Bar Code (HIBC) to identify a
device. (Ref. 3) We believe roughly 35 to 50 percent of all medical
devices used in the United States are already labeled with device
identifiers that conform to one of the systems operated by these two
organizations (a 2005 ECRI Institute report, ``Automatic Identification
of Medical Devices,'' cited survey data suggesting bar codes were
currently found on 25 percent of class I devices, 44 percent of class
II devices, and 50 percent of class III devices) (Ref. 4). These
existing systems are providing valuable services to device user
facilities (hospitals, nursing homes, and other facilities) and to
health care professionals. These systems have proven to be successful
in creating unique identifiers that are in widespread use in systems
used by hospitals, healthcare professionals, and industry.
    Because these existing systems include tightly-integrated functions
that go far beyond simply identifying devices--functions such as
inventory management and enabling commercial transactions that are not
part of FDA's public health responsibilities and are outside our
statutory authority--FDA believes it would be inefficient and
counterproductive to try to replace the existing systems with a single,
FDA-designed system of device identifiers. Because any FDA system would
necessarily have a narrow scope limited to the adequate identification
of devices, labelers would have to continue to use the existing systems
as well as the FDA system, which would result in duplication of effort,
substantial

additional costs, and potentially confusing identification of devices
that would undermine our public health objectives. Consequently, FDA's
proposed UDI system will permit continued use of these existing
systems, so long as the administering organizations apply for and
obtain FDA accreditation, as discussed under question 5 of section II.C
of this document. The GUDID will allow rapid access to key information
concerning any device labeled with a UDI, regardless of the system used
to assign the UDI.
    Burdens should be minimized.
    We have honed our proposed data submission requirements to minimize
overlap and avoid inconsistency with other existing FDA regulatory
requirements, such as establishment registration and device listing. We
are proposing to require the submission of fewer types of data than
those identified and discussed in the public meetings (Ref. 5) that
influenced development of this proposed rule. See proposed Sec.
830.310. We are requesting comments on whether we have adequately
minimized overlap and inconsistency, and whether we should require or
permit the submission of additional data that may be useful to the
healthcare community.
    The UDI system should be open to technological advancements.
    The proposed rule would require each UDI to be provided in both a
plain-text form and a form that uses AIDC technology. See proposed
Sec.  801.45. FDA would not require use of any particular technology
for the AIDC form of the UDI. The system would permit the use of any
type of bar code, RFID tag, near-field communication, or any other
technology, whether existing at the present time or developed in the
future. This would allow for technological evolution and advancement
without prior FDA approval. FDA expects that a new technology would be
deployed only after considerable consultation among issuing agencies,
device user facilities, healthcare professionals, and device
manufacturers, and we believe such decisions are best left in the hands
of the healthcare community.
    The UDI system should be designed to integrate smoothly with other
FDA systems, such as registration and listing, postmarket surveillance,
and adverse event reporting.
    We have taken care to avoid conflict and minimize overlap with
existing regulatory requirements, and we have included several
conforming amendments to existing regulatory requirements to ensure
UDIs are integrated in our regulatory processes wherever appropriate
and feasible. For example, Part 810--Medical Device Recall Authority,
Part 820--Quality System Regulation and Part 821--Medical Device
Tracking Requirements.
    Requirements should be phased in over several years to ensure
smooth and effective implementation.
    Pursuant to the proposed tiered effective dates, UDI requirements
would be phased in over seven years following publication of a final
rule (see table 7 of this document). This would allow all
participants--FDA, industry, the health care community, and other
government agencies--ample time to become familiar with and phase-in
the rule's labeling and data submission requirements. This approach
also provides FDA the opportunity to identify unforeseen weaknesses or
problems in our implementation of the UDI system and to make
appropriate mid-course corrections within the scope and authority of
this rule, if finalized. We are proposing to phase in the rule's
requirements by class because this will allow us to focus first on
devices that have higher risks.
    The UDI system should foster innovation by, and competition among,
issuing agencies.
    The proposed rule would allow for accreditation of multiple issuing
agencies, see proposed Sec.  830.100, so that the varying needs of
labelers and users of different types of devices can be met by
different systems with differing levels of complexity and function.
Because all issuing agencies would have to employ systems based on the
same technical standards, and would have to meet the same accreditation
requirements, each system would still be broadly compatible with other
systems. Furthermore, all systems would employ the FDA-administered
GUDID database, which would serve as the single authoritative source of
information for the positive identification of any device labeled with
a UDI. We will maintain a list of all FDA-accredited issuing agencies
on our Internet site.
    There will be effective FDA oversight of issuing agencies.
    Oversight is necessary to ensure that all device identifiers are
unique and meet the proposed requirements, and that all system users
are treated fairly. FDA is proposing to require that any organization
that wishes to issue UDIs be accredited by FDA. See proposed Sec.
830.20(a). We have included accreditation criteria and information
submission requirements designed to ensure that only a well-qualified
organization that would issue identifiers that comply with the proposed
rule would be permitted to serve as an issuing agency. See proposed
Sec. Sec.  830.100 and 830.110.
    The UDI system should provide for appropriate regulatory
flexibility, including exceptions and alternatives.
    Where possible, we have included reasonable flexibility in our
proposal. For example, certain categories of devices would be excepted
from UDI requirements, see proposed Sec.  801.30, and labelers may
request an exception or propose an alternative that would, for example,
provide for more effective identification of a device, see proposed
Sec.  801.35. Direct marking requirements would apply only to certain
narrow categories of devices and there would be some flexibility in how
this requirement may be satisfied, see proposed Sec.  801.50. We seek
comment on whether these flexibilities achieve the appropriate balance.
    Safeguards should be provided to protect small businesses.
    We seek to do this in two ways. First, a business can choose to use
any system provided by any accredited issuing agency, which will give
the labeler a choice among a range of services at a range of fees. We
anticipate that the participation of multiple issuing agencies will
also lead to competition that will help ensure fees are reasonable.
Second, FDA may act as an issuing agency if we find that a significant
number of small businesses will be substantially harmed by the fees
assessed by all accredited issuing agencies, see proposed Sec.
830.200. If FDA acts as an issuing agency, any business would be
permitted to use the FDA system and, under current law, there would be
no fee, see proposed Sec.  830.210. We expect this provision will
encourage issuing agencies to be sensitive and responsive to the needs
of small businesses.
    The establishment of a publicly accessible GUDID database is a
critical component of an effective UDI system.
    It is important to understand that a UDI is simply a numerical or
alphanumerical code and on its face is not itself intended to
communicate any information directly concerning a device; you would
not, for example, be able to parse out a segment that indicates that
the device is a cardiovascular device, or that the device is packaged
sterile, or that the device is marketed under a particular FDA
premarket submission. Instead, the UDI would function as a reference
number allowing you to find data concerning the device in an FDA
database, the GUDID. The real value of a UDI is derived from its
connection to corresponding information identifying the version or

model of the device that bears the UDI, and an effective system of
device identification requires both a UDI and a database to provide
information concerning the particular version or model identified by
that UDI. Our proposal would require the submission of information
essential to the identification of a device, which would be provided
freely and publicly through a single authoritative source, the GUDID.
    In order to serve the public health purposes discussed in section
I.A of this document, the UDI system requires a GUDID that is freely
and easily accessible to all--hospitals and other device user
facilities, health care practitioners, patients, other government
agencies, academia, industry, and the general public. None of the
information that we are proposing to collect would constitute trade
secret information, confidential commercial information, or personal
privacy information, and public disclosure of this information would
not be prohibited. Open access to the GUDID would also encourage the
integration of UDI data into healthcare delivery support systems,
electronic medical records, and procurement, inventory management, and
accounting systems, and would allow those systems to work together more
effectively and efficiently.

D. Prior Consultation With the Health Care Community and Industry

    In the Federal Register of February 26, 2004 (69 FR 9120), we
published a final rule requiring bar codes on certain human drug and
biological products to help reduce medication errors in hospitals and
other health care settings. The bar code is intended to enable health
care professionals to use bar code scanning equipment in conjunction
with computerized medication administration systems to verify that the
right drug, in the right dose, is being given to the right patient at
the right time. This rule, now codified at 21 CFR 201.25 and 610.67,
requires that manufacturers encode the unique National Drug Code (NDC)
number in a linear bar code on the product's label. The bar code rule,
however, does not apply to medical devices. In the preamble to the bar
code rule, we stated that, unlike drugs, medical devices do not have a
standardized, unique identifying system comparable to the NDC number,
and that the absence of such a system complicates efforts to put bar
codes on medical devices for purposes of preventing medical errors (69
FR 9120 at 9132).
    Since the issuance of the final bar code rule, various entities
have asked that we revisit the issue of bar coding for medical devices
to improve patient safety, quality of care, and cost effectiveness of
health care, e.g., by improving delivery and supply chain efficiency.
In response to this, in 2005 FDA met with various stakeholders,
including device manufacturers and distributors, hospital associations,
and other Federal agencies to solicit information and comments about
employing a uniform system for the unique identification of medical
devices. As a result of these meetings, FDA believes the majority of
stakeholders support the development of a uniform system of unique
identifiers as a way to improve patient safety and recognize other
ancillary benefits such as better management of the purchase,
distribution, and use of medical devices. However, there were a variety
of experiences and opinions about how best to implement such a system.
In 2006, we commissioned a report from Eastern Research Group, Inc.
(ERG), concerning the benefits, costs, and issues with developing and
implementing a UDI System. (Ref. 6) Thereafter, we published a notice
in the Federal Register of August 11, 2006 (71 FR 46233), requesting
comments to help us understand how a unique device identification
system could improve patient safety, for example, by reducing medical
errors, facilitating device recalls, and improving medical device
adverse event reporting.
    We used the comments responding to the August 2006 Federal Register
notice to help develop the agenda and topics for a public meeting held
on October 25, 2006. (Ref. 5) The information we received helped us
move forward with development of a proposed rule, which was further
spurred by enactment of FDAAA.
    FDA held a public workshop on February 12, 2009, to discuss issues
relating to establishment of a UDI system (see 74 FR 2601, January 15,
2009). (Ref. 5) We asked device identification standards organizations
to discuss the development and use of UDI standards, including the use
of production identifiers. We asked device manufacturers to discuss the
use of standards and the marking of devices with UDIs. We also
discussed the potential development and use of a UDI database in
general and with respect to particular attributes, as well as issues
relating to implementation of a UDI system by interested stakeholders
(e.g., distributors, hospitals, payors). We asked device manufacturers
to describe their current practices for applying standards to medical
devices, including identifiers on medical device labels, and managing
medical device identifier data. We also requested information regarding
the difficulties and costs involved in adding a UDI to a device's
label, including effects on manufacturing and labeling processes and
expected capital and operating costs. We asked device user facilities
(hospitals, nursing homes, and clinics) to describe how a UDI system
could be used, the costs involved, whether a UDI system would require
any change in operations, and how UDIs would affect adverse event
reporting and recall management. We asked all interested persons to
submit comments, including answers to any of these questions, to a
regulatory docket, FDA-2008-N-0661, CDRH 200866--Unique Device
Identification System; Public Workshop. Comments received by the docket
may be reviewed at http://www.regulations.gov by searching for ``FDA-
2008-N-0661'' (enter this text in the search field following ``Enter
Keyword or ID'').
    We carefully reviewed and considered all comments during our
development of this proposed rule.

II. Description of the Proposed Rule

A. Overview

    The core requirements summarized here provide context for the more
detailed discussions that follow:
     Proposed Sec.  801.18 provides for standardized formatting
of dates on medical device labels, eliminating any possibility of
confusion from date formats that might be interpreted in more than one
way.
     The labeler of each device would be responsible for
meeting labeling and data submission requirements under this proposal.
The labeler would, in most instances, be the manufacturer of the
device. The term ``labeler'' is defined at proposed Sec.  801.3, and is
discussed in section II.B.1 of this document.
     Unless the device is excepted, the label of a medical
device, and a device package, marketed in the United States would be
required to bear a UDI; this requirement would be phased in over 5
years. See proposed Sec.  801.20.
     The UDI would have to be provided in two forms: easily-
readable plain-text and AIDC technology. See proposed Sec.  801.45.
These two forms ensure that the UDI of a device would be readily
discernable to patients and health care professionals and to automated
systems used to identify and manage devices.
     The proposed rule provides several categorical exceptions,
proposed Sec.  801.30, as well as case-by-case

exceptions and alternatives, proposed Sec. Sec.  801.35 and
801.128(f)(2).
     Direct marking would be required for certain categories of
devices, with exceptions. For each device subject to direct marking,
this requirement would go into effect two years after the base UDI
labeling requirement goes into effect for that device. See proposed
Sec.  801.50.
     Whenever a device must be labeled with a UDI, the labeler
(the person who causes the label to be applied to the device) would
have to submit data concerning that device to the GUDID database. See
proposed Sec.  830.320. This information would have to be submitted no
later than the date the label of the device must bear a UDI, and would
have to be updated when changes occur. See proposed Sec.  830.330.
Exceptions are identified in the detailed discussion of part 830. This
data would be freely available to the public and would provide the
information necessary to identify a device labeled with a UDI.
     UDI labeling requirements would also apply to--
    [cir] Certain combination products;
    [cir] In most instances, to the device constituent parts of
combination products;
    [cir] Convenience kits; and
    [cir] A device included in a convenience kit, except for a single
use device.
    The terms ``combination product'' and ``convenience kit'' are
defined at proposed Sec.  801.3 and are discussed in section II.B.1 of
this document.
     UDIs would be issued under systems operated by FDA-
accredited ``issuing agencies'' and conform to certain international
standards, incorporated by reference at proposed Sec.  830.10. A
different UDI would be required for each version or model of a device.
These terms are defined at proposed Sec.  830.3.
     In order to provide for efficient implementation of this
rule, we propose to phase in its requirements over several years. Table
7 of this document, Effective Dates of UDI Regulatory Requirements,
summarizes how we would phase in the requirements proposed in this
rule.

B. UDI Labeling Requirements (Part 801)

    Part 801 (21 CFR part 801) provides FDA's general medical device
labeling requirements. All devices are subject to subparts A through E
of part 801, while subpart H provides special requirements for specific
devices; subparts B, F, and G are presently reserved. FDA provides
additional labeling requirements in subpart B of part 809 that apply
only to in vitro diagnostic products. FDA is proposing amendments to
part 801 to provide UDI labeling requirements for devices. The changes
we are proposing to part 801 provide a new definitions section, see
proposed Sec.  801.3; a new provision standardizing the format of dates
provided on medical device labels, see proposed Sec.  801.18; new
subpart B, Labeling Requirements for Unique Device Identification; and
a proposed amendment to Sec.  801.128, regarding exceptions or
alternatives to labeling requirements for medical devices held by the
Strategic National Stockpile. Several definitions proposed for
inclusion in part 801 would also be included in new part 830, Unique
Device Identification. A proposed amendment to Sec.  801.119 (the
labeling regulation specifically applicable to in vitro diagnostic
devices) would make it clear that all UDI labeling requirements apply
to such devices. In order to avoid confusion with regard to the use of
National Health Related Item Codes (NHRICs) and NDC numbers currently
used to identify some devices, proposed Sec.  801.57 would terminate
the use of these legacy identifiers on the date the device must be
labeled with a UDI; those dates are specified in proposed Sec.
801.20(b).
1. Definitions
    The UDI regulation would not change the meaning of any term
currently defined in Part 801. We are proposing, in new Sec.  801.3,
several definitions relating to the use of UDIs on device labels. New
Sec.  801.3 would not affect the existing definitions in part 801, and
would not consolidate existing part 801 definitions into a single
section. Each definition proposed in Sec.  801.3 is discussed in this
section II.B.1.
    Automatic identification and data capture (AIDC) technology would
be any technology that conveys the UDI or the device identifier of a
device in a form that can be entered into an electronic patient record
or other computer systems via an automated process. AIDC technologies
most often use bar codes, RFID, or near field communication, but this
rule does not specify the technologies that may be used and does not
prohibit the use of any particular technology. We believe it is best to
leave decisions concerning the selection and use of any particular AIDC
technology to issuing agencies, the labeler, and the health care
community in order to avoid unintentional interference with the
development and adoption of new and improved AIDC technology.
    Center Director--This would be the Director of the Center for
Devices and Radiological Health, or the Director of the Center for
Biologics Evaluation and Research, depending on which Center has lead
responsibility for a particular device.
    Combination product--Within the context of the UDI system, a
combination product will involve at least one device and at least one
drug or one biological product. The term is defined by 21 CFR 3.2(e),
and would have the same meaning here. A combination product whose
primary mode of action is that of a device is subject to UDI labeling
requirements; see proposed Sec.  801.25(a). The constituent parts of a
combination product would continue to be subject to all requirements
that ordinarily apply to the particular type of product (device; drug;
biologic), and this rule would require each device constituent part of
a combination product to be labeled with its own UDI, regardless of
whether the combination product is subject to UDI labeling. For
example, the device constituent parts of a combination product whose
primary mode of action is that of a drug would be subject to UDI
labeling requirements; see proposed Sec. Sec.  801.25(b). However, a
device constituent part of a combination product would not be required
to have a UDI if it is physically, chemically, or otherwise combined
with other constituents of the combination product in such a way that
it is not possible for the device constituent part to be used except as
part of the use of the combination product; see proposed Sec.
801.30(a)(11). A drug-eluting stent is an example of a combination
product where the device constituent part--the bare-metal stent--has
been combined with a drug constituent in such a way that it is not
possible for the stent to the used except as part of the combination
product.
    Convenience kit--When two or more different types of medical
devices are packaged together for the convenience of the user, the
result is a convenience kit. A convenience kit would have to have a
UDI; see proposed Sec.  801.25(c). Each device in a convenience kit
would have to meet all FDA requirements that normally apply to a device
of that type, including having its own UDI distinct from that of the
convenience kit, except for single use devices included in a
convenience kit; see proposed Sec.  801.25(d).
    Device package--This definition is intended to clarify which
articles would be required to bear a UDI under proposed Sec.
801.20(a)(2). It is also intended to clarify the scope of the term
version or model, which includes this term in its definition
(consistent with current business practice, a change to the quantity of
devices in a device

package is one of the changes that results in a new version or model;
see proposed Sec.  830.50 and related discussion under the heading
``Version or model'' of this section II.B.1). Since these requirements
would be consistent with current practices--the existing GS1 and HIBCC
systems, and the standards that underlie both of those systems and the
proposed FDA UDI system--they will be well-understood, there will be no
need for multiple identifiers on device packages, and we will avoid any
need for duplicative and inconsistent identification.
    This term would be defined as a package that contains a fixed
quantity of devices. A package may be a box or any other type of
container in which devices are distributed or sold, and would include
packages within other packages. Unlike a shipping container, whose
contents and quantity may vary between shipments, the quantity of a
device package would remain constant. If you change the quantity in a
device package, you will have created a new device package. FDA is
proposing this definition because the existing GS1 and HIBCC systems,
and the international standards that underlie those systems, all
require differentiation among packages that contain different
quantities of a device in order to facilitate inventory management,
order processing, and other business purposes. The proposed UDI system
needs to recognize and accommodate these existing business systems and
practices to avoid creating requirements that would lead the healthcare
community and industry to have to devise a supplementary system to
implement the UDI system, which would unnecessarily impose added costs
and burdens and potentially undermine the effectiveness of the UDI
system if multiple types of identifiers were used. We invite comment on
this understanding of current systems and the extent to which the
proposed definition accommodates current practice. A change to a device
package that does not make substantive changes to the information
conveyed thereon or to the quantity in the package would not result in
a new device package; for example, a change in graphics, fonts, colors,
or formatting would not result in a new device package, but a change in
quantity would result in a new device package.
    Finished device--This term is defined because it is used in the
definition of lot or batch, which is discussed below. In turn, the
definition of lot or batch is based on a definition in FDA's Quality
System Regulation.
    Expiration date--This term is not defined in any other medical
device regulation, but is in common use and an expiration date (or
``use by'' date) is frequently provided on the labels of FDA-regulated
products, including medical devices. The proposed definition is
intended to capture the term's ordinary meaning, which we take to be
the date by which the label of a device states the device must or
should be used. We are defining the term because it is one of four
production identifiers that, when provided on a device's label, would
also have to be provided through a UDI (the other production
identifiers are: The lot or batch of a device; the serial number of a
device; and the date a device was manufactured); see the proposed
definition of unique device identifier, which includes production
identifier.
    FDA, we, or us would mean the Food and Drug Administration.
    Global Unique Device Identification Database (GUDID) would mean the
FDA administered database that serves as a repository of information to
facilitate the identification of medical devices through their
distribution and use. This term would have the same definition in both
parts 801 and 830; more information is provided later in this preamble,
in the discussion of definitions used in part 830.
    Implantable device would mean a device that is intended to be
placed in a surgically or naturally formed cavity of the human body. A
device would be regarded as an implantable device only if it is
intended to remain implanted continuously for a period of 30 days or
more, unless the Commissioner determines otherwise in order to protect
human health.
    Label would have the same meaning as is provided by section 201(k)
of the FD&C Act.
    Labeler--This term would mean any person who causes a label to be
applied to a device, or who causes the label to be modified, with the
intent that the device will be 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.
The labeler would be responsible for meeting the UDI labeling
requirements proposed for inclusion in part 801.
    The addition of the name of, and contact information for, a person
who distributes the device, without making any other changes to the
label, would not be a modification for the purposes of determining
whether a person is the labeler. If a modification to the label extends
beyond this narrow latitude, the person who causes the modification to
be made will be a labeler and will be subject to the requirements of
this rule.
    The term labeler does not include a person who labels a device, or
who modifies the label of a device, pursuant to the instructions of the
person who actually places the device into interstate commerce. Thus, a
contractor who labels a device, following the instructions of the
specification developer or manufacturer, would not be the labeler.
Instead, the person who ``causes'' the label to be applied or
modified--the person who provided the labeling instructions, whose name
is on the device, and who actually places the device into interstate
commerce (FDA refers to such a person as a specification developer)--
would be the labeler and would be responsible for meeting UDI labeling
requirements.
    Lot or batch--This definition is based on the definition used in
the Quality System Regulation (QSR), Sec.  820.3(m), but deletes the
QSR language concerning components and the condition ``whether or not
it is packaged, labeled, or sterilized.'' This is because UDI
requirements would not apply until the device is labeled, and
sterilization would not be a factor in determining whether a device
would have to bear a UDI (the need for sterilization prior to each use
would be relevant in determining whether a device must be directly
marked under proposed Sec.  801.50). Lot or batch is one of four
production identifiers that, when provided on a device's label, must be
provided through a UDI. See the proposed definition of unique device
identifier.
    Shipping container--A shipping container would be a package,
container, or pallet that is used for the shipment or transportation of
devices from one point to another and whose contents may vary from one
shipment to another. This rule would not require a UDI to be placed on
any shipping container; see proposed Sec.  801.30(b).
    Specification--This definition is intended to clarify the scope of
``specification'' as used in the definition of version or model. This
definition builds on the definition of ``specification'' provided by
the QSR, see Sec.  820.3(y), but uses ``device'' instead of ``product,
process, service, or other activity,'' because the QSR has a wider
scope.
    Unique device identifier (UDI)--The definition cites proposed Sec.
830.20, which specifies the requirements for a valid UDI, and the
statutory mandate of

the UDI system: To adequately identify a device through its
distribution and use. A UDI may consist of two parts--
     A device identifier that identifies the specific version
or model of a device and the labeler of that device; and
     A production identifier that identifies one or more of the
following, when present on the label of the device:
    [cir] The lot or batch within which a device was manufactured;
    [cir] The serial number of a specific device;
    [cir] The expiration date of a specific device;
    [cir] The date a specific device was manufactured.
    The production identifier would not be required for class I
devices; see Sec.  801.30(c). The device identifier would always have
to be present in a UDI. The production identifier must be present
whenever a lot or batch number, serial number, date of manufacture, or
expiration date appears on the label of the device, except for class I
devices. Because most device labels provide at least one of these
identifiers, most UDIs would have to include a production identifier.
This proposed rule would not itself require any production identifier
to appear on a device label, but other FDA regulations and conditions
of approval may require one or more to be provided on the label of a
particular device or type of device, and many labelers already label
their devices with one or more production identifiers.
    As discussed in section I.B of this document, the UDI is not
structured to provide direct information concerning a device; the
device identifier is a reference number that allows you to find data
concerning the device in an FDA database, the GUDID. Whenever this
proposed rule states that a UDI ``identifies'' a device, we are
referring to the use of the UDI in conjunction with information
concerning the device that the labeler of the device has submitted to
the GUDID.
    Universal product code (UPC)--A universal product code is an
identifier used to identify a company and product name for an item sold
at retail in the United States. UPCs are based on the GS1 ``General
Specification,'' an international standard.
    Version or model--This definition identifies the characteristics
that make a device unique. Each version or model would be required to
have its own device identifier, and when you add a new version or
model, or make a change that results in a new version or model, that
addition or change would require use of a new device identifier and
would require you to submit information concerning the version or model
to the GUDID. See proposed Sec. Sec.  830.50 and 830.330. The
definition combines elements from definitions in the QSR for finished
device and lot or batch, Sec. Sec.  820.3(l) and (m), and includes
language to make clear that each distinct device package (each
containing a different quantity of devices) would constitute a
different version or model (and would therefore have its own device
identifier).
2. When would the requirement for UDI labeling go into effect, and
where would the UDI have to appear?
    Proposed Sec.  801.20(a) would require medical device labels and
device packages to bear a UDI. Exceptions to this general rule are
provided by proposed Sec. Sec.  801.30, 801.35, and 801.128(f)(2), and
are discussed in section II.B.7 of this document.
    Thus, if a device is sold in individual device packages, which are
sold in boxes of five device packages, which are sold in cartons that
contain ten boxes of five device packages, a UDI would be required to
appear on the individual device package, on the box of five packages
(which is itself a ``device package,'' see proposed 801.3, because it
contains a fixed number of devices), and on the carton of ten boxes of
five device packages (again, because the carton is a ``device
package''). This reflects existing practice within the health care
community; both the existing GS1 and HIBCC systems, and the standards
that underline those systems and the proposed FDA UDI system, follow
this approach, and place an unique identifier on every distinct device
package (Ref. 7).
    The presence of a UDI on each device package would improve the
effectiveness and efficiency of recalls and other corrective actions
targeting potentially harmful devices. For example, the presence of a
UDI on outer packaging will enable distributors, hospitals, and others
to enter it into their system upon receipt. Then they will know exactly
what devices they have or had in their possession when, and if, there
is a recall, tampering, counterfeiting, or other problems with the
device at a later date, they can simply type in the applicable UDIs to
determine whether they have (or had) the device in their possession. If
there were no UDI on the outer packaging, the box or other type of
container would need to be opened to access it, which could facilitate
tampering and contribute to the very problems that the UDI system is
designed to remedy.
    By requiring a UDI for device packages, the proposed UDI system
strives for uniform identification of devices throughout their path of
distribution and use. This will facilitate the unambiguous
identification of devices wherever they are located and avoid the
confusion that would be created by the use of multiple identifiers, and
that would undermine the public health purposes of the rule. At
present, most manufacturers generally follow this approach, and place
an identifier on every device package (Ref. 7). If UDIs were not
required to appear on all device packages, manufacturers would continue
to use their existing identification systems, which would result in the
use of multiple types of identifiers for a particular device. This
would produce confusion and inhibit the rapid and precise
identification of devices that is the goal of this rule. The fact that
the proposed requirements are consistent with existing practices also
lowers the burden of compliance.
    The requirement for device labels and device packages to bear a UDI
would be phased in over several years:
     UDI labeling requirements will take effect for class III
devices and devices licensed under the Public Health Service Act
beginning 1 year after we publish a final rule; see proposed Sec.
801.20(b)(1).
     UDI labeling requirements will take effect for class II
devices beginning 3 years after we publish a final rule; see proposed
Sec.  801.20(b)(2).
     UDI labeling requirements will take effect for class I
devices and devices not classified into class I, II, or III beginning 5
years after we publish a final rule; see proposed Sec.  801.20(b)(3)
and (b)(4).
    See table 7 of this document for a summary of these and other
effective dates proposed for this rule.
    Phasing in UDI labeling requirements over several years allows all
parties--FDA, device labelers, hospitals and other device user
facilities, and health care professionals--to prepare for, and
implement, the requirements in an orderly, efficient manner. It also
provides FDA the opportunity to clarify any confusion in implementation
within the scope and authority of this rule, after it is finalized. We
are proposing to phase in UDI labeling and data submission requirements
by class because this will allow us to focus first on devices that have
higher risks. Section 801.25 explains how these timeframes apply to
convenience kits and combination products.
    The data reporting requirements of part 830 would go into effect at
the same time as the UDI labeling requirements, see proposed Sec.
830.330(a), using the same phased-in schedule as is set forth in
proposed Sec.  801.20(b). These parallel

requirements--UDI labeling and data reporting--would go into effect
together because, as discussed in section I.B of this document, the UDI
would have limited value without the ability to look up information
concerning the device in a database.
3. How would UDI labeling requirements apply to a combination product
and a device constituent part of a combination product?
    Proposed Sec.  801.25(a) would require a UDI on the label and
device package of every combination product whose primary mode of
action is that of a device, regardless of which FDA Center has been
designated as having primary jurisdiction for the premarket review and
regulation of the product (in the great majority of cases where the
combination product has a primary mode of action of a device, the lead
Center will be the Center for Devices and Radiological Health). If FDA
has determined that the primary mode of action of a combination product
is not that of a device, we would not require a UDI on the label or
package of the combination product. For a combination product with a
primary mode of action other than that of a device, we envision that
the combination product generally would be identified by an NDC (see 21
CFR 201.25, 610.67; 71 FR 51276, August 29, 2006).
    Proposed Sec.  801.25(b) would require a UDI on the label and (when
present) the device package of each device constituent part of a
combination product, regardless of the primary mode of action of the
combination product, which Center has the lead responsibility for the
combination product, and whether the label and package of the
combination product are required to bear a UDI, except where the device
constituent part is physically, chemically, or otherwise combined with
other constituents of the combination product in such a way that it is
not possible for the device constituent part to be used except as part
of the use of the combination product; see proposed Sec.
801.30(a)(11). Thus, whenever it is possible for a device constituent
part to be used separately from a combination product with a device
primary mode of action, a UDI would be required to identify the
combination product, and a different UDI would be required for each
device constituent part that can be used separately from the use of the
combination product. This approach is necessary both for the accurate
identification of the product, and to facilitate effective recalls and
adverse event reporting. For example, there may be a problem with a
device constituent part of a drug-device combination product that
applies only to the device when it is part of the combination product,
or only to the device when used separately from the combination
product. We seek comments on this approach to UDI applicability to
combination products.
    With the exception of those products where it is not possible for
the device constituent part to be used except as part of the
combination product, the presence of either a UDI or an NDC on the
label and package of combination products, and a UDI on the label and
any device package of each device constituent part thereof, would
assure precise identification.
4. How would UDI labeling requirements apply to a convenience kit?
    A convenience kit consists of two or more different types of
medical devices packaged together for the convenience of the user. We
propose to require a UDI on the label of and device package of each
convenience kit. See proposed Sec.  801.25(c). We would also require
each device in a convenience kit to bear its own UDI (a UDI distinct
from that of the convenience kit) on its label and device package
unless the included device is intended for a single use (e.g., an
adhesive bandage). See proposed Sec.  801.25(d). The reason for
requiring a UDI on the label and device package of each device in a
convenience kit is that devices that are intended for more than a
single use, such as surgical instruments that are sometimes packaged as
parts of kits, often become separated from the convenience kit, and are
used at some later time. Without a UDI, there is no assurance that the
user will be able to adequately identify the device and be aware of
relevant data in the GUDID database concerning that device. Because
this potential problem is much less of a concern for a device intended
for a single use, a single-use device included in a convenience kit
would not need to bear a UDI; see proposed Sec.  801.30(a)(12).
Inclusion in a convenience kit would have no effect on whether a device
must be directly marked pursuant to proposed Sec.  801.50; if Sec.
801.50 requires the device to be directly marked, the device must be
directly marked regardless of whether it is included in a convenience
kit.
5. Exceptions From, and Alternatives to, UDI Labeling Requirements
    The proposed rule would provide several exceptions to our UDI
labeling requirements. The exceptions derive from statutory provisions
or are designed to make the overall UDI system more efficient and to
ensure that the burdens imposed by the UDI system are reasonably
balanced with its benefits. A labeler that chooses for business or
other reasons to voluntarily comply with any provision from which the
labeler is excepted may, of course, do so.
    Proposed Sec.  801.30(a)(1) provides an exception for devices,
other than prescription devices, that are sold at retail
establishments, such as drug stores; this exception would also apply to
such devices when sold directly to a hospital or other health care
facility. A wide range of devices is available at retail, including
automatic external defibrillators, insulin syringes, glucometers,
tampons, thermometers, toothbrushes, bandages, and more. We are
providing this exception to reduce the overall burden of the proposed
rule, given that it is the prevailing industry practice to label such
devices with a UPC, which may serve as an adequate substitute for
devices sold over-the-counter at retail. For those labelers that choose
to submit data to the GUDID on a voluntary basis, a UPC may serve as a
UDI for devices sold at retail for purposes of submission of data to
the GUDID; see proposed Sec.  830.300(c).
    Some devices sold over-the-counter at retail have been the subject
of recalls and adverse events, and we would likely see significant
benefits from participation in the UDI system. It is also possible that
many other devices sold over-the-counter at retail would benefit from
participating in the UDI system, and that those benefits would outweigh
the costs of participation. Because of our uncertainty regarding the
balance of interests regarding proposed Sec. Sec.  801.30(a)(1), FDA
requests comments on the extent to which devices sold in retail
establishments should be subject to the requirements of this proposed
rule. Should these devices be excepted as provided by proposed
Sec. Sec.  801.30(a)(1), or should they instead be subject to the
proposed rule in the same manner and to the same extent as other
devices?
    Proposed Sec.  801.30(a)(2) would except from UDI labeling
requirements any class I device that FDA has by regulation exempted
from the good manufacturing practice (GMP) requirements of part 820,
the Quality Systems Regulation. If such a regulation requires that a
class I device remain subject to Sec.  820.180, with respect to general
requirements concerning records, or Sec.  820.198, with respect to
complaint files, that device would nevertheless qualify for this
exception.
    These are very simple devices, such as--
     Tuning fork (product code GWX)

     Elastic bandage (product code FQM)
     Examination gown (product code FME)
     Bedpan (product code FOB)
     Manual toothbrush (product code EFW)
    We have provided a list of the devices that at present would be
eligible for this exception; see Ref 10. FDA is providing this list to
illustrate the scope of this exception at the time of this proposed
rule.
    Proposed Sec.  801.30(a)(3) provides an exception for individual
class I, single-use devices, all of a single version or model, that are
distributed together in a single package, whose uses are generally
known to the persons by whom they are intended to be used, and which
are not intended or promoted for individual sale. Those devices would
not have to be individually labeled with a UDI. For example, this
includes devices that are not individually wrapped (e.g., a box of
patient examination gloves) and devices that are individually wrapped
and bear identifying information, but which are not intended to be
distributed individually (e.g., a box of adhesive bandages). In such
cases, applying a UDI on each individual device would not be likely to
contribute to better identification of the device and would be an
unnecessary burden and cost. The device package containing these
individual devices must, however, bear a UDI on its label.
    Proposed Sec.  801.30(a)(3) would apply only to class I devices
because we believe that only class I devices are currently marketed in
the manner contemplated by Sec.  801.30(a)(3). It is not our intent to
require changes to current practices regarding the packaging of
devices, and we are specifically seeking comment regarding this
exception in question 15 of section IX of this document. Labelers of
class II devices that would qualify for this exception but for their
classification may request an exception or alternative under proposed
Sec.  801.35.
    Proposed Sec.  801.30(a)(4) provides an exception for a device used
solely for research, teaching, or chemical analysis, and not intended
for any clinical use, as is consistent with FDA's general approach to
the regulation of such articles as set out in 21 CFR 801.125.
    Proposed Sec.  801.30(a)(5) provides an exception for a custom
device, or a device made to meet the unique needs of a patient or
physician, within the meaning of Sec.  812.3(b). This exception is
consistent with FD&C section 520(b), which provides that FD&C sections
514, Performance Standards, and 515, Premarket Approval, do not apply
to custom devices. Because a custom device is intended only for use by
an individual patient and not generally available for sale, a UDI would
not be necessary to uniquely identify the device.
    Proposed Sec.  801.30(a)(6) provides an exception for an
investigational device within the meaning of part 812 (21 CFR part
812). Investigational devices are subject to a variety of requirements
under part 812 that ensure adequate identification of the device.
    Proposed Sec.  801.30(a)(7) provides an exception for a veterinary
medical device not intended for use in the diagnosis of disease or
other conditions in man, in the cure, mitigation, treatment, or
prevention of disease in man, or intended to affect the structure or
any function of the body of man.
    Proposed Sec.  801.30(a)(8) provides an exception for a device
intended for export from the United States. This is because foreign
nations have their own regulatory requirements, which may include
identification requirements, with which the device must conform.
    Proposed Sec.  801.30(a)(9) provides an exception for a device held
by the Strategic National Stockpile and granted an exception or
alternative under Sec.  801.128(f)(2). This exception is consistent
with other labeling exceptions that apply to devices held by the
Strategic National Stockpile. For background on the Strategic National
Stockpile, see FDA's Interim Final Rule concerning Exceptions or
Alternatives to Labeling Requirements for Products Held by the
Strategic National Stockpile (72 FR 73601, December 28, 2007).
    Proposed Sec.  801.30(a)(10) provides an exception for a device for
which FDA has established a standard pursuant to section 514(b) of the
FD&C Act and has provided therein an exception from the requirement of
proposed Sec.  801.20, or for which FDA has recognized all or part of a
standard pursuant to section 514(c) of the FD&C Act and has included an
exception from the requirement of proposed Sec.  801.20 within the
scope of that recognition. This exception is intended to provide FDA
flexibility in the application of the UDI system, or an alternative,
when we are using a standard as a special control for a particular
device.
    Proposed Sec.  801.30(a)(11) provides an exception for a device
constituent part of a combination product, provided that the device
constituent part of a combination product is physically, chemically, or
otherwise combined with other constituents of the combination product
in such a way that it is not possible for the device constituent part
to be used except as part of the use of the combination product. If it
is possible for the device constituent part to be used in any way
except as part of the use of the combination product, this exception
does not apply. See discussion under preceding question 3.
    Proposed Sec.  801.30(a)(12) provides an exception for a device
that is packaged in a convenience kit, provided that the device is
intended for a single use. This exception does not apply if the device
is intended for more than one use. See discussion under preceding
question 4.
    Proposed Sec.  801.30(b) provides an exception for shipping
containers, because they often contain different, unrelated devices,
and sometimes other items as well. We do not propose to require a UDI
be placed on any shipping container, but the device packages within the
shipping container would be subject to all UDI labeling requirements
unless an exception applies under proposed Sec. Sec.  801.30(a), 801.35
or 801.128(f)(2).
    Proposed Sec.  801.30(c) provides an exception that would permit
the labeler of a class I device to label it with a UDI that does not
include any production identifiers; the UDI would only have to include
the device identifier. Most Class I medical devices include a plain
text version of relevant production identifiers (e.g., a lot number or
an expiration date) somewhere on the device label. However, the cost of
encoding production identifiers in dynamic barcodes for high-volume
class I device production lines may outweigh the benefits of this
enhanced identification. Furthermore, we believe that hospitals may be
less likely to track or document individual class I device use in
patient records, and are more likely to simply use a more-generic
identifier; the device identifier portion of the UDI will adequately
serve such needs. Labelers of class I devices are not prohibited from
using a production identifier, but they would not be required to do so
under this proposed rule.
    Proposed Sec.  801.35 authorizes additional, case-by-case, labeling
exceptions beyond those provided by proposed Sec.  801.30; this section
also authorizes alternatives to standard UDI labeling requirements.
This provision is intended to ensure that the UDI system has adequate
flexibility to accommodate any special circumstances regarding a
particular device or type of device that indicate that application of
the standard UDI labeling requirements is not technologically feasible
or that the objectives of this rule would be better served by
application of an alternative approach. Only a device labeler may
request an exception or alternative

under proposed Sec.  801.35, although FDA may, under proposed Sec.
801.35(d), provide an exception or alternative on our own initiative. A
request for an exception or alternative under proposed Sec.  801.35
would have to--
     Identify the device that would be subject to the exception
or alternative;
     Identify the UDI labeling requirements that are the
subject of the request for an exception or alternative;
     If requesting an exception, explain why the UDI labeling
requirements are not technologically feasible;
     If requesting an alternative, describe it and explain how
it would provide for more accurate, precise, or rapid device
identification than the standard requirements or how the alternative
would better ensure the safety or effectiveness of the device;
     Provide an estimate of the number of labelers and the
number of devices that would be affected if we grant the requested
exception or alternative.
    See proposed Sec.  801.35(a). We may request additional information
needed to clarify the scope or effects of a request; see proposed Sec.
801.35(a)(6).
    A request under proposed Sec.  801.35 could be submitted to FDA as
part of a premarket submission, proposed Sec.  801.35(b), or through a
written request at any time after a premarket submission has been
filed, proposed Sec.  801.35(c). If we grant a request for an exception
or alternative, we may include conditions to ensure the adequate
identification of the device through its distribution and use, given
the anticipated circumstances of use. If we grant an exception or
alternative, we would provide information about the exception or
alternative on our Internet site. If necessary to facilitate or
implement an alternative granted under this section, FDA may, at our
discretion, act as an issuing agency; see proposed Sec.  830.200(d).
6. May a device that is exempt from UDI labeling requirements
nevertheless be labeled with a UDI?
    Yes. Proposed Sec.  801.40(a) permits the labeler of a device that
is not required to bear a UDI to voluntarily include a UDI on the label
of that device. We have included this provision because it may be in
the interest of both labelers and their customers to use the same
identification system for all devices, and not just those devices that
this rule requires to bear a UDI. If the labeler voluntarily includes a
UDI on the label of a device, the labeler may also voluntarily provide
information concerning the device to the GUDID; see proposed Sec.
830.300(c). We expect most labelers who voluntarily label their devices
with UDIs will choose to voluntarily submit information to the GUDID in
order to facilitate the identification of those devices.
7. How would a UDI have to appear on a device label and on a device
package?
    We would require the UDI to be provided on the device label and
each device package in an easily-readable, plain-text form. This is so
patients, health care professionals, FDA, and other users of the UDI
system would be able to read the UDI and enter it, at their discretion,
into patient records, reports to FDA, and data systems without any
technological assistance. We do not specify a particular font or point
size for the UDI; rather, the UDI would be subject to existing
requirements that govern medical device labels, including Sec.  801.15,
concerning prominence of required label statements.
    The UDI would have to be provided on device labels and device
packages through AIDC technology; see Sec.  801.45(a)(2). The AIDC
version will facilitate efficient and accurate identification of the
device, documentation of the use of the device in electronic records,
and potentially many other uses, while reducing the possibility of
human error. The AIDC technology may be a bar code, RFID, near-field
communications (NFC), or any other technology that serves the same
objectives. We do not specify what technologies may be used, because
the most appropriate technology will vary considerably depending on the
type of device and its intended uses, and because the available
technologies are likely to evolve and advance over time.
    At present, we believe most device labelers would choose to meet
the requirement for AIDC technology by providing a bar code. In such
instances, the bar code may be formatted in any way that meets the
technical requirements of the bar coding system that is employed.
    While the presence of a bar code is immediately obvious, the
presence of other AIDC technologies, such as RFID and near-field
communication, may not be so obvious. If a device user is not aware of
the availability of AIDC technology, this may impair the rapid and
accurate identification of the device. To ensure that the presence of
AIDC technology is obvious, if the AIDC technology is not visible on
the label of the device or on the device package, the labeler would
also have to include a symbol on the device label or on the device
package that provides notice of the presence of AIDC technology; see
proposed Sec.  801.45(c). The symbol may be a symbol endorsed in an
international or national standard recognized by FDA under section
514(c) of the FD&C Act (for example, symbols specified for differing
types of RFID systems), a symbol generally recognized by the persons
who typically use the device, or the generic symbol shown in proposed
Sec.  801.45(c).
8. When would a device have to be directly marked with a UDI?
    We restrict our proposed direct marking requirements, proposed
Sec.  801.50, to three categories of devices, because these devices
present unique risks that we believe would be better controlled through
direct marking:
     An implantable device;
     A device that is intended to be used more than once and
that is intended to be sterilized before each use; and
     Stand-alone software that is a ``device'' under Sec.
201(h) of the FD&C Act.
    An implantable device, proposed Sec.  801.50(a)(1)--An implantable
device is, by definition, intended to be used for at least 30 days (see
the proposed definition of implantable device at Sec.  801.3). Once
implanted, the device is separated from its label and labeling, which
may prevent accurate identification of the device over time,
potentially undermining the accuracy of problem reporting and delaying
the identification and resolution of problems with the implanted
device. But if the UDI is evident upon explantation of the device, or
is retrievable through AIDC technology, it will still be possible to
unambiguously identify the implant.
    A device that is intended to be used more than once and that is
intended to be sterilized before each use, proposed Sec.
801.50(a)(2)--These devices may also be used over an extended period of
time, with the need for effective cleaning and sterilization before
each new use providing a complicating factor. It is particularly
important to understand precisely the identity of each such device,
because effective sterilization methods may be different for different
types of devices. If a device is not effectively sterilized, and is
then used on a patient, severe harm may result. UDI labeling, and the
associated data available from the GUDID, will help ensure device users
have the information they need to avoid such harm.
    Stand-alone software, proposed Sec.  801.50(a)(3)--This category
excludes software that is an integrated component of a device, such as
software embedded in a chip that is part of a circuit in a device. This
includes stand-alone software that meets the definition

of ``device'' under Sec.  201(h) of the FD&C Act, e.g., prostate auto-
contouring software that assists clinicians in generating estimates of
the anatomy boundary contours of the prostate gland in computed
tomography scans, magnetic resonance images, and ultrasound scans to
aid in patient diagnosis, treatment planning, and post-treatment
monitoring. Stand-alone software is unique in that it may be possible
to obtain, use, and update it without ever receiving a physical package
bearing a physical label. For example, software may be initially
obtained via the Internet, and it is very common for patches, updates,
and new versions to be provided through the Internet. Furthermore, even
when the software is identical to the package and label description, it
is typically used only after being installed on a computer (or multiple
computers, or on a network) and typically the package and label (and
the physical media, such as a CD-ROM or DVD-ROM) are no longer used.
Additionally, software may be transferred from one installation to
another without any external indication. All of these factors make it
highly likely that users of stand-alone software will not have ready
access to the package or label, or if they do, that the software
differs from the label description. By requiring a simple form of
direct marking as part of the software itself, we overcome these
problems and ensure that users can readily and precisely identify
stand-alone software. In contrast to stand-alone software, software
that is a component of a device will be adequately identified by the
UDI on that device's label and package.
    The form of direct marking that would be required depends on which
of these categories the device falls within. See proposed Sec.
801.50(c). If your device is an implantable device, or is intended to
be used more than once and to be sterilized before each use, the direct
marking would have to be provided through either or both of the
following:
     Easily-readable plain-text;
     AIDC technology, or any alternative technology that will
allow for identification of the device. Examples include providing the
UDI of the device on demand to an external reader or sensor, or making
the UDI or a barcode or other representation of the UDI discernible to
an x-ray or other imaging system.
    If your device is stand-alone software, the direct marking would
have to be provided through either or both of the following:
     An easily-readable plain-text statement displayed whenever
the software is started;
     An easily-readable plain-text statement displayed in
response to a menu command (e.g., an ``About * * *'' command).
    We seek comments about the utility of marking stand-alone software
in this manner.
    The UDI conveyed by the direct marking may be either the UDI that
appears on the label of the device, or a different UDI used to
distinguish the unpackaged device from the device while it remains in
packaged form. See proposed Sec.  801.50(b). We permit the use of a
different UDI to distinguish the unpackaged device because that is
consistent with both current direct marking practices and the
objectives of this rule.
    The requirement for direct marking of a device would go into effect
two years after the date specified by proposed Sec.  801.20 for the
device to bear a UDI on its label; see proposed Sec.  801.50(d). We
believe this will provide the labeler adequate time to implement an
appropriate direct-marking methodology for any device that would be
subject to the requirements of proposed Sec.  801.50. We seek comments
on whether this is an appropriate amount of time in which to make this
provisions effective.
    Although our proposed direct marking requirements apply only to the
three categories of devices identified by proposed Sec.  801.50(a), we
recognize that even within those categories, direct marking will not
always be appropriate or feasible. Proposed Sec.  801.50(e) provides
reasonable exceptions to the requirement for direct marking; direct
marking would not be required when any of the following apply--
     Direct marking would interfere with the safe and effective
use of the device; proposed Sec.  801.50(e)(1). For example, it is
possible that direct marking would interfere with the safe and
effective use of orthopedic bone screws because direct marking could
adversely affect the structural integrity of the screw. Direct marking
may also interfere with the safe and effective use of instruments used
in arthroscopic surgery because direct marking could create irregular
surfaces that could reduce the effectiveness of sterilization
procedures and harbor bacteria or other pathogens.
     Direct marking is not technologically feasible; proposed
Sec.  801.50(e)(2). To be technologically feasible, it must be possible
to place a direct marking on the device using readily-available
technology, and it must be possible for that direct marking to be read
in the environments it is intended to be used, again using readily-
available technology (generally meaning technologies that are typically
present in the environment where the device is used).

For example, it is not technologically feasible to directly mark
polymethylmethacrylate (PMMA) bone cement, classified at Sec.
888.3027, because bone cement is sold in an amorphous state. Similarly,
at the present time it is not technologically feasible to directly mark
an aqueous shunt, classified at Sec.  886.3920, because the small size
of the device would not permit inclusion of RFID or near-field
communication, and any barcode, even if technically possible to apply,
would be extraordinarily difficult to read with existing technologies.
The technological feasibility of directly marking a device may change
over time as new technologies are developed, enabling more direct
marking options.
    In addition, the ``not technologically feasible'' exception from
direct marking under Sec.  801.50(e)(2) can include circumstances,
where, for a very small firm, the capital investment in technology to
allow direct part marking so exceeds to benefit of applying the
requirement that FDA could find direct part marking to be ``not
technologically feasible.'' Factors to be considered in this instance
would include: The number of devices otherwise subject to direct
marking across which the capital investment can be amortized, current
net earnings on expected sales of such devices, and the number of years
required to recover the capital investment based on net earnings. FDA
believes, however, when considering whether economic factors justify an
exception under the ``not technologically feasible'' language, FDA
should retain discretion to also consider the public health benefits of
direct marking for a particular device based on its usage and risks.
     The device is intended to remain implanted continuously
for a period of less than 30 days, unless the Commissioner determines
otherwise in order to protect human health; proposed Sec.
801.50(e)(3). This exception is inherent in the definition of
implantable device, but is provided for clarity.
     The device has been previously directly marked; proposed
Sec.  801.50(e)(4) We are proposing this exception both because of the
practical difficulty and potential for confusion involved in applying a
new direct marking when a direct marking already exists, and because
multiple markings may compromise the device. We believe that continued
use of the original direct marking will provide an adequate means to
identify the device through its distribution and use. A labeler may,

however, remark a previously-marked device if the labeler concludes, on
the basis of its own evaluation, that re-marking the device would not
adversely affect the safety or effectiveness of the device.
     The device is sold at retail and bears a Universal Product
Code (UPC); Sec.  801.50(e)(5).
     The device is software that is not stand-alone software,
but is a component of a medical device; Sec.  801.50(e)(6). Examples of
a software device that is not stand-alone include software incorporated
into devices such as infusion pumps and software integrated and used to
control systems such as MRI machines.
    If you determine that your device qualifies for an exemption from
direct marking, you would have to document the basis of your decision
in the design history file as required by Sec.  820.30(j) of the
Quality System Regulation, see Sec.  801.50(f). If you determine that
your device qualifies for an exemption from direct marking because
direct marking would interfere with the safe and effective use of the
device, see proposed Sec.  801.50(e)(1), or because you determine the
device cannot be marked because it is not technologically feasible, see
proposed Sec.  801.50(e)(2), you would have to send a notice to FDA,
see proposed Sec.  801.50(g). Your notice to FDA would have to provide
the following information:
     Identification of the exception, or exceptions, authorized
by proposed Sec.  801.50(e) that you are invoking.
     An explanation of the factors that make the exception
applicable to your device.
     The name of, and contact information for, the person who
determined that the exception is applicable to your device.
    FDA does not intend to routinely respond to notices submitted under
proposed Sec.  801.50(g). If we have a question concerning your notice,
we may request additional information, review information in your
device history records when we conduct an establishment inspection, or
take such other action as may be appropriate.
9. After the requirement for UDI labeling goes into effect, May I
continue to identify my device with the National Health-Related Item
Code (NHRIC) or National Drug Code (NDC) number assigned to it?
    No; see proposed Sec.  801.57. FDA is phasing out the use of NHRIC
and NDC numbers to identify medical devices, in favor of the UDI
system. On the date your device would have to be labeled with a UDI,
any NHRIC or NDC assigned to that device will be rescinded, and you
will no longer be permitted to label your device with an NHRIC or NDC.
Continued use of NHRIC or NDC codes on device labels and device
packages would result in confusion concerning the appropriate
identification of the device, and might obscure the distinction between
drug and device identification systems. We seek comments on whether
there are compelling reasons to continue to permit the use of these
numbering systems.
10. Formatting of Dates Provided on Medical Device Labels
    Proposed Sec.  801.18 would require all dates provided on medical
device labels to conform to a specified format: Month Day, Year, with
the month shown as a three-letter abbreviation of the month (e.g. SEP
30, 2012). This format--Month Day, Year (SEP 30, 2012)--is the format
most commonly used in the United States and is the format most familiar
to patients and consumers. Dates may be printed in any size and font
that meet the general labeling requirements of part 801.
    When dates are formatted to use only numbers, inconsistencies in
formatting from one device to another can lead to confusion concerning
the proper interpretation of the date. For example, the expiration date
January 12, 2013 may, at present, be expressed as 1-12-2013 (this is
the format most commonly used in the United States) or as 12-1-2013
(this is the format most commonly used in Europe). This could cause a
patient or a health care professional to mistakenly continue to use the
device for more than 10 months past the intended expiration date.
Another source of potential confusion is the use of date formats that
use only the month and year, such as 12-2011, 12-11, or December 2011.
The omission of the precise day of the month creates uncertainty; 12-
2011 could indicate that use of the device should cease on the first
day of December 2011, or the last day of December 2011. Furthermore,
when a date uses a two-digit representation of year, it may not be
clear that the number sequence represents a date. Use of a standard
format consistent with the usage most often used and most readily
recognized by consumers in the United States will eliminate any
potential confusion concerning the appropriate interpretation of dates
provided on medical device labels. (Ref. 8)
    The proposed date format may contribute to more accurate
identification of a device by making it possible to distinguish between
those devices that have passed an expiration or use-by date and those
that have not. More accurate identification would make it easier to
both avoid the risks of using ``expired'' devices and the costs of
premature disposal of devices that have not actually reached an
expiration or use-by date.
    We provide a limited exception in proposed Sec.  801.18(f) for
electronic products to which a standard is applicable under subchapter
J, Radiologic Health; 21 CFR 1010.3(a)(2)(ii) specifies the date format
for such electronic products. We do not believe it is necessary to
change this requirement for these products, because that standard uses
the month and year of production, which does not involve the potential
for confusion that an expiration date or use-by date may present.
    Proposed Sec.  801.18 would go into effect one year after we
publish a final rule. We believe Sec.  801.18 should be implemented as
rapidly as possible because it is designed to correct existing
confusion concerning the interpretation of dates on medical device
labels. We seek comments on whether this date format and associated
effective date are feasible and appropriate, including whether the
effective date should be linked to the UDI implementation date for each
class of devices.

C. Requirements Relating to Issuing Agencies and Submission of Data to
the Global Unique Device Identification Database (Part 830)

    New part 830 would provide FDA's requirements for the composition
and issuance of UDIs, explain the process FDA would follow to accredit
an ``issuing agency'' to operate a system for the issuance of UDIs,
explain when FDA would act as an issuing agency, and would provide
requirements pertaining to the GUDID, including when and what data must
be submitted to the GUDID and by whom.
1. Definitions
    We are proposing, in new Sec.  830.3, definitions for important
terms used by FDA's unique device identification system under this
rule. The terms proposed for inclusion in Sec.  830.3 are discussed in
this section II.C; where a term is also defined in part 801, the
definitions are identical.
    The following terms would have the same definition in both parts
801 and 830; these terms are discussed earlier in this preamble--
     Automatic identification and data capture (AIDC).
     Device package.
     Expiration date.

     FDA, we, or us.
     Labeler.
     Lot or batch--This definition includes a definition of
finished device.
     Specification.
     Shipping container.
     Unique device identifier (UDI).
     Universal product code (UPC).
     Version or model.
    The following additional terms are defined in proposed Sec.
830.3--
    Issuing agency--This term would mean an organization accredited by
FDA to operate a system for the issuance of UDIs. Our proposed rule
permits multiple issuing agencies, and under certain circumstances FDA
could act as an issuing agency.
    Global Unique Device Identification Database or GUDID--This term
would mean the FDA-administered database that serves as a repository of
information to facilitate the identification of medical devices through
their distribution and use. The device identifier portion of a UDI
would not be structured to provide specific information concerning a
device; rather, the device identifier would serve as a reference number
that would allow you to find information about the device by accessing
information reporting to the GUDID. For example, you would not be able
to parse out a segment that indicates that the device is a
cardiovascular device, or that the device is packaged sterile, or that
the device is marketed under a particular FDA premarket submission.
    Premarket submission--This term would mean any of the following
types of applications:
     Premarket approval application--an application for
approval of a device submitted under section 515(c) of the FD&C Act.
     Product development protocol--the application described in
section 515(f) of the FD&C Act.
     Premarket report means a report submitted under section
515(c)(2) of the FD&C Act.
     Humanitarian device exemption application--an application
for approval of a humanitarian use device submitted under section
520(m) of the FD&C Act.
     Biologics license application means an application for
approval of a device submitted under section 351 of the Public Health
Service Act.
     Premarket notification submission means a report submitted
under section 510(k) of the FD&C Act.
     New drug application for a transitional device means a new
drug application for a medical device that was regulated by FDA as a
new drug prior to May 28, 1976, the date of enactment of the Medical
Device Amendments of 1976.
    Small business--This term would mean a medical device manufacturer
with 500 or fewer employees, or a medical device relabeler or
repackager with 100 or fewer employees. This is consistent with how the
Small Business Administration defines ``small business'' under the
Small Business Act (5 U.S.C. 631). We are proposing this definition
only to help explain when FDA would act as an issuing agency under
proposed subpart D of part 830.
2. What would be the requirements for the composition and issuance of a
valid Unique Device Identifier?
    In order to ensure that all UDIs will meet the public health
objectives of this rule, and to ensure that device user facilities,
health care professionals, FDA, and others will be able to make
efficient and effective use of the UDI system, we are proposing every
UDI must be issued under a system operated by FDA or an FDA-accredited
issuing agency, see proposed Sec. Sec.  830.20(a), and must conform to
the international standards that would be incorporated by reference by
proposed Sec.  830.10. UDIs would have to be composed only of
characters from a single character set defined by one of these
incorporated standards; see proposed Sec.  830.20(b). Conformity to
these international standards will ensure that each issuing agency's
system of assigning UDIs will be broadly compatible and capable of
fulfilling our public health objectives.
    Incorporation by reference of ISO/IEC 646:1991, Information
technology--ISO 7-bit coded character set for information exchange,
would limit the plain-text version of a UDI to a particular set of