[Federal Register Volume 78, Number 185 (Tuesday, September 24, 2013)]
[Rules and Regulations]
[Pages 58786-58828]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-23059]



[[Page 58785]]

Vol. 78

Tuesday,

No. 185

September 24, 2013

Part V





Department of Health and Human Service





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 Food and Drug Administration





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





Unique Device Identification System; Final Rule

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

[[Page 58786]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

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


Unique Device Identification System

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

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

FOR FURTHER INFORMATION CONTACT: Jay Crowley, UDI Regulatory Policy 
Support, Center for Devices and Radiological Health, Food and Drug 
Administration, Bldg. 66, Rm. 3303, 10903 New Hampshire Ave., Silver 
Spring, MD 20993-0002, 301-796-5995, email: [email protected].

SUPPLEMENTARY INFORMATION:

Executive Summary

Purpose of the Regulatory Action

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

[[Page 58787]]

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

Summary of the Major Provisions of the Regulatory Action in Question

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

[[Page 58788]]

Costs and Benefits

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

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

[[Page 58789]]

    N. General Exceptions from the Requirement for the Label of a 
Device To Bear a Unique Device Identifier--Exception for a Device 
Held by the Strategic National Stockpile and Granted an Exception or 
Alternative Under Sec.  801.128(f)(2)--Sec.  801.30(a)(9)
    O. General Exceptions from the Requirement for the Label of a 
Device To Bear a Unique Device Identifier. The Unique Device 
Identifier of a Class I Device Is Not Required to Include a 
Production Identifier--Sec.  801.30(c)
    P. Requests for Additional General Exceptions from the 
Requirement for the Label of a Device To Bear a Unique Device 
Identifier
    Q. Request for Modification of Unique Device Identifier Labeling 
Requirements for Devices That Have Small Labels
    R. Voluntary Labeling of a Device With a Unique Device 
Identifier--Proposed Sec.  801.40; Revised Requirements at Sec.  
801.35
    S. Form of a Unique Device Identifier--Technical Requirements--
Proposed Sec.  801.45(a); Sec.  801.40(a) of the Final Rule
    T. Form of a Unique Device Identifier--Unique Device Identifier 
to Include Device Identifier and Production Identifier--Proposed 
Sec.  801.45(b); Revised Requirements at Sec.  801.40(b) of the 
Final Rule
    U. Form of a Unique Device Identifier--Proposed Symbol to 
Indicate the Presence of Automatic Identification and Capture 
Technology--Proposed Sec.  801.45(c); Revised Requirements at Sec.  
801.40(c) of the Final Rule
    V. Form of a Unique Device Identifier--Effect of Labeling a 
Class I Device With a Universal Product Code--New Sec.  801.40(d) of 
the Final Rule
    W. Changes to Codified Text in Response to Comments on 
Requirements Proposed in Sec.  801.50--Devices That Must Be Directly 
Marked With a Unique Device Identifier
    X. Devices That Must Be Directly Marked With a Unique Device 
Identifier--Proposed Requirement for an Implantable Device To Bear a 
Permanent Marking Providing the Unique Device Identifier on the 
Device Itself--Proposed Sec.  801.50(a)(1)
    Y. Revision of Direct Marking Requirements--Proposed Sec.  
801.50; Sec.  801.45 of the Final Rule
    Z. Devices That Must Be Directly Marked With a Unique Device 
Identifier--Proposed Requirement for Submission of a Notice to FDA 
Upon Determining That an Exception Applies--Proposed Sec.  801.50(g)
    AA. Requirements for Stand-Alone Software--Final Sec.  801.50
    BB. Request for an Exception from or Alternative to a Unique 
Device Identifier Requirement--Proposed Sec.  801.35; Sec.  801.55 
of the Final Rule
    CC. Discontinuation of Legacy Identification Numbers Assigned to 
Devices (National Drug Code and National Health-Related Item Code 
Numbers)--Sec.  801.57
    DD. Requests for Clarification Concerning Whether Compliance 
With Any Unique Device Identifier Requirement Will Require 
Submission of a 510(k) Premarket Notification or Premarket Approval 
Supplement
    EE. Human Cells, Tissues, or Cellular or Tissue-Based Products 
That are Regulated as Devices--Sec. Sec.  801.3 and 801.20(a)(1)
    FF. Technical Standards Applicable to Part 830--Sec.  830.10
    GG. Requirements for a Unique Device Identifier--Sec.  830.20
    HH. Use and Discontinuation of a Device Identifier--Sec.  830.40
    II. Changes That Require Use of a New Device Identifier--Sec.  
830.50
    JJ. FDA Accreditation of an Issuing Agency--Sec.  830.100
    KK. Information Required for Unique Device Identification--Sec.  
830.310
    LL. Information Required for Unique Device Identification--
Information Concerning Each Version or Model of a Device--Sec.  
830.310(b)
    MM. Enforcement Authority
    NN. Questions and Comments Suggesting the Need for Additional 
Guidance
    OO. Requests for Additional Opportunity for Comment Prior to 
Issuing a Final Rule
III. Legal Authority for the Final Rule
IV. Analysis of Impacts
    A. Summary of Impacts
    B. Summary of Regulatory Flexibility Analysis
    C. Summary of Benefits
V. Information Collection Requirements
VI. Environmental Impact
VII. Effective Dates
    A. Effective Dates
    B. Compliance Dates
VIII. Federalism
IX. References

I. Background

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

[[Page 58790]]



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

[[Page 58791]]

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

[[Page 58792]]

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

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

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

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

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

[[Page 58793]]

packaging reflects prevailing industry practices (Refs. 3, 14, and 15). 
Similarly, different UDIs are useful for each different device package 
because a device recall might target a specific device package while 
excluding other device packages; in addition, the requirement for 
different UDIs on different device packages recognizes current industry 
practices, which generally use different identifiers for each level of 
packaging and for packages with different quantities of devices. 
Accordingly, we have not modified the definition of device package in 
response to comments. Because packages that contain a convenience kit, 
an in vitro diagnostic product, an HCT/P regulated as a device, or a 
combination product with a device constituent part all contain a 
particular version or model of a device, such packages also meet the 
definition of ``device package'' and are required to bear a UDI by 
Sec.  801.20.
    Six comments argued that a UDI should be required to appear only on 
the label of a device, and not on higher levels of packaging based on 
the premise that section 519(f) of the FD&C Act narrowly requires a UDI 
only on the device label.
    FDA disagrees with this comment. As explained in the preamble to 
the amended proposed rule, the presence of a UDI on the higher-level 
packaging of a device will enable FDA to more efficiently and 
effectively respond to a reported device problem by using its 
regulatory tools, such as notification or mandatory recall under 
section 518 of the FD&C Act (21 U.S.C. 360h), tracking under section 
519(e), ensuring the adequacy of a voluntary recall with the assistance 
of reports of corrections and removals as required by section 519(g), 
or seizing a device that is adulterated under section 501 (21 U.S.C. 
351) and/or misbranded under section 502 (21 U.S.C. 352). Thus, the 
provisions of the final rule requiring a UDI on higher-level packaging 
are issued in aid of FDA's authority under all of these sections of the 
FD&C Act, as well as under the Agency's broad authority to issue 
enforcement regulations under section 701(a) (21 U.S.C. 371(a)) and its 
specific authority to implement UDI requirements to identify devices 
``through distribution and use'' of the device under section 519(f). 
(See 77 FR 69393 at 69395.) Requiring a UDI on device packages enables 
the UDI to serve its purposes of assisting with tracking, recalls, and 
enforcement with respect to devices that have not yet been removed from 
their package, for example for devices located at distributors or in 
hospital inventory, while avoiding any need to open or tamper with the 
device packaging.
    Finished device--We did not receive any comments concerning this 
definition. This term is used in the definition of lot or batch, and is 
included to clarify the meaning of that term. This term is also useful 
when determining the ``date of manufacture'' that should be used as a 
production identifier; see the discussion of Unique device identifier 
(UDI)--Production identifier, in this document.
    HCT/P regulated as a device--We have added this definition, and 
made other changes that are discussed later in this document, to 
explain how the final rule applies to HCT/Ps that are regulated as 
devices.
    Implantable device--Comments suggested FDA should remove the 30-day 
threshold that restricts the direct marking requirement to devices 
intended to remain implanted continuously for a period of 30 days or 
more.
    Such a change would result in unwarranted inconsistency with 
longstanding regulatory practice. For example, the definitions of 
implant used in 21 CFR parts 812 (investigational device exemptions) 
and 860 (medical device classification procedures) use the same 30-day 
criterion. The final rule adopts the definition provided by the 
proposed rule, without change. We note further that because FDA has 
removed the requirement of direct marking for implants, the definition 
of implantable device under the final rule is no longer relevant to the 
scope of the direct marking requirement.
    Labeler--A comment suggested that the definition's use of language 
referring to ``the intent that the device will be introduced into 
interstate commerce'' is not appropriate. Another comment suggested 
that the final rule should make clear that a health care system 
assembling ``convenience kits'' for distribution within its own system 
should not be a ``labeler'' and that such distribution is not 
interstate commerce. A somewhat similar comment suggested that 
``Hospitals, health care systems, and other entities that repackage 
devices, assemble kits, or reprocess single-use devices for internal 
use only . . . should not be subject to UDI-related requirements. . . 
.''
    We believe that all of these concerns can be resolved by modifying 
the definition to refer to ``commercial distribution,'' a term that has 
been in use for many years and which is used extensively in FDA's 
medical device regulations. The term ``commercial distribution'' is 
defined by Sec.  807.3(b) and we intend for that definition to apply 
here. ``Commercial distribution'' means any distribution of a device 
intended for human use which is held or offered for sale, but does not 
include internal transfer of a device between establishments within the 
same parent, subsidiary, or affiliate company.
    Comments suggested FDA should modify the definition to include a 
``relabeler'' or should define ``relabeler.''
    FDA agrees a relabeler is a labeler under this rule. We expected 
that our use of ``modified'' in paragraph (2) of the definition would 
have been understood to include ``replaced.'' FDA does not believe that 
introducing the term ``relabeler'' would provide greater clarity. 
Instead FDA believes we can better clarify our intended meaning by 
amending paragraph (2) of the definition to begin, ``Any person who 
causes the label of a device to be replaced or modified. . . .'' The 
final rule adopts this change.
    Another comment suggested that the final rule ``must more 
specifically describe when a repackager, device reprocessor, or other 
non-manufacturer would be . . . considered a `labeler' for UDI 
purposes.''
    FDA disagrees. This rule is not changing the meanings of repackager 
or reprocessor; those terms will have the same meanings as they now 
have within other regulatory contexts, such as registration and listing 
and premarket review, and thus would be considered labelers.
    Lot or batch--A comment requested clarification regarding how this 
term should be applied to HCT/Ps, ``where the donor identification is 
of singular importance.'' Other comments mirrored this concern, stating 
that devices ``derived from human tissue cannot be labeled by lot or 
batch, unless the lot or batch identification is associated with a 
single donor, as [21 CFR] 1271.220(b) disallows the pooling of human 
cells or tissue from two or more donors during manufacturing.''
    FDA agrees that these are valid concerns, but we believe that the 
phrases ``manufactured under essentially the same conditions'' and 
``intended to have uniform characteristics and quality within specified 
limits'' in the definition of lot or batch are flexible enough to 
include the distinct identification code required by Sec.  1271.290(c). 
FDA has, however, addressed the concerns of these comments in another 
way. To clearly accommodate HCT/Ps regulated as devices, the final rule 
includes additional language in the definition of production identifier 
(part of the definition of unique device identifier);

[[Page 58794]]

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

B. Applicability of Sec.  801.20

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

C. Compliance Dates of Unique Device Identifier Regulatory Requirements

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

[[Page 58795]]

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

[[Page 58796]]

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

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

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

[[Page 58797]]

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

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

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

[[Page 58798]]

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

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

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

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

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

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

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

[[Page 58799]]

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

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

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

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

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

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

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

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

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

[[Page 58800]]

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

M. Medical Procedure Kits and Trays

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

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

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

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

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

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

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

[[Page 58801]]

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

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

    Some comments suggested the rule should provide an exception from 
UDI labeling requirements ``where the label is too small'' to 
accommodate both human readable and AIDC information, ``provided that 
the UDI appears on the next higher level of packaging.'' A similar 
comment suggested that if a device with a small label is included in a 
convenience kit, a UDI should be required only on the label of the 
convenience kit.
    FDA believes that some of the concerns underlying these requests 
have been resolved by the revisions made to Sec.  801.30, which 
provides general exceptions from the requirement for the label of a 
device to bear a UDI. For example, under the final rule, except for 
implantable devices, we have extended to all classes the exception for 
individual single-use devices, all of a single version or model, that 
are distributed together in a single device package, and which are not 
intended for individual commercial distribution (see Sec.  
801.30(a)(3)), and a UDI is not required on the label of the device 
constituents of combination products and the contents of convenience 
kits as long as the label of the combination product or convenience kit 
bears a UDI (see Sec.  801.30(a)(11)).
    FDA does not agree that any additional exception should be provided 
in the final rule based only on the size of the device label. First, 
the comments we received did not provide sufficient information to 
allow FDA to establish objective criteria to guide labelers in deciding 
when a device label or package would be ``small enough'' to qualify for 
any exception we might provide. Second, none of the comments we 
received provided sufficient information to evaluate the reach of an 
exception based on size. For these reasons, we believe it is preferable 
that requests for an exception or alternative to UDI requirements based 
on label size be evaluated through the process provided by Sec.  801.55 
of the final rule; this provision is explained in the section II.BB 
``Request for an Exception from or Alternative to a Unique Device 
Identifier Requirement--Proposed Sec.  801-35; Sec.  801.55 of the 
Final Rule.'' Accordingly, we are not making any special provision 
concerning the labeling of small devices, and we expect the labels of 
devices of all sizes to bear a UDI as required by the final rule.

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

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

[[Page 58802]]

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

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

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

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

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

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

    Proposed Sec.  801.45(c) would have required a device label or 
device package to bear a symbol indicating the presence of AIDC 
technology whenever the AIDC ``is not evident upon visual examination 
of the label or device package.'' The proposed language identified the 
types of symbols that could be used. Among the types of symbols 
permitted was an FDA-proposed generic symbol.
    We received many comments (approximately 40) on this proposal. None 
of these comments expressed support for the FDA-proposed generic 
symbol. Many suggested that only specific internationally recognized 
symbols should be permitted, and some suggested each issuing agency 
should specify the symbols that would be used. Some comments went 
further, and objected to the provision in its entirety; these comments 
were primarily concerned that an AIDC symbol would crowd label space 
and lead to confusion, particularly if the provision permitted 
different labelers to choose different symbols.
    In response to these comments, FDA has simplified this provision, 
now at Sec.  801.40(c), so that it requires that the label or device 
package disclose the presence of AIDC technology without specifying 
how. We deleted the authorized use of an FDA-proposed generic symbol. 
We believe this approach addresses the concerns of device users that 
the FDA symbol will crowd label space and be confusing or conflict with 
other expectations of the issuing agency, while providing labelers 
greater flexibility and reduced burdens.

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

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

[[Page 58803]]

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

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

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

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

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

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

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

[[Page 58804]]

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

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

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

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

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

[[Page 58805]]

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

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

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

[[Page 58806]]

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

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

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

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

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

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

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

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

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

[[Page 58807]]

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

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

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

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

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

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

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

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

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

[[Page 58808]]

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

[[Page 58809]]

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

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

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

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

[[Page 58810]]

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

MM. Enforcement Authority

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

NN. Questions and Comments Suggesting the Need for Additional Guidance

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

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

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

III. Legal Authority for the Final Rule

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

[[Page 58811]]

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

IV. Analysis of Impacts

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

A. Summary of Impacts

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

[[Page 58812]]



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

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

B. Summary of Regulatory Flexibility Analysis

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

C. Summary of Benefits

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

[[Page 58813]]

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

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

V. Information Collection Requirements

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

[[Page 58814]]

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

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

[[Page 58815]]

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


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

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

VI. Environmental Impact

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

VII. Effective Dates

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

[[Page 58816]]



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

VIII. Federalism

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

IX. References

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

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

[[Page 58817]]

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

List of Subjects

21 CFR Part 16

    Administrative practice and procedure.

21 CFR Part 801

    Labeling, Medical devices, Reporting and recordkeeping 
requirements.

21 CFR Parts 803, 806, and 821

    Imports, Medical devices, Reporting and recordkeeping requirements.

21 CFR Part 810

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

21 CFR Part 814

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

21 CFR Parts 820 and 822

    Medical devices, Reporting and recordkeeping requirements.

21 CFR Part 830

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

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

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

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

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

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


Sec.  16.1  Scope.

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

PART 801--LABELING

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

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

Subpart A--[Amended]

0
4a. Add new Sec.  801.3 to read as follows:


Sec.  801.3  Definitions.

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

[[Page 58818]]

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

0
4b. Add new Sec.  801.18 to subpart A to read as follows:


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

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

0
5a. Effective October 24, 2013, add subpart B consisting of Sec.  
801.55 to read as follows:

Subpart B--Labeling Requirements for Unique Device Identification


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

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

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

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

[[Page 58819]]

Sec.  801.20  Label to bear a unique device identifier.

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


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

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


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

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


Sec.  801.40  Form of a unique device identifier.

    (a) Every unique device identifier (UDI) must meet the technical 
requirements of Sec.  830.20 of this chapter. The UDI must be presented 
in two forms:
    (1) Easily readable plain-text, and
    (2) Automatic identification and data capture (AIDC) technology.
    (b) The UDI must include a device identifier segment. Whenever a 
device label includes a lot or batch number, a serial number, a 
manufacturing date, an expiration date, or for a human cell, tissue, or 
cellular or tissue-based product (HCT/P) regulated as a device, a 
distinct identification code as required by Sec.  1271.290(c) of this 
chapter, the UDI must include a production identifier segment that 
conveys such information.
    (c) If the AIDC technology is not evident upon visual examination 
of the label or device package, the label or device package must 
disclose the presence of AIDC technology.
    (d) A class I device that bears a Universal Product Code (UPC) on 
its label and device packages is deemed to meet all requirements of 
subpart B of this part. The UPC will serve as the unique device 
identifier required by Sec.  801.20.


Sec.  801.45  Devices that must be directly marked with a unique device 
identifier.

    (a) In general. A device that must bear a unique device identifier 
(UDI) on its label must also bear a permanent marking providing the UDI 
on the device itself if the device is intended to be used more than 
once and intended to be reprocessed before each use.
    (b) UDI for direct marking. The UDI provided through a direct 
marking on a device may be:
    (1) Identical to the UDI that appears on the label of the device, 
or
    (2) A different UDI used to distinguish the unpackaged device from 
any device package containing the device.
    (c) Form of a UDI when provided as a direct marking. When a device 
must bear a UDI as a direct marking, the UDI may be provided through 
either or both of the following:
    (1) Easily readable plain-text;
    (2) Automatic identification and data capture (AIDC) technology, or 
any alternative technology, that will provide the UDI of the device on 
demand.
    (d) Exceptions. The requirement of paragraph (a) of this section 
shall not apply to any device that meets any of the following criteria:
    (1) Any type of direct marking would interfere with the safety or 
effectiveness of the device;
    (2) The device cannot be directly marked because it is not 
technologically feasible;
    (3) The device is a single-use device and is subjected to 
additional processing and manufacturing for the purpose of an 
additional single use.
    (4) The device has been previously marked under paragraph (a) of 
this section.

[[Page 58820]]

    (e) Exception to be noted in design history file. A labeler that 
decides to make use of an exception under paragraph (d of this section) 
must document the basis of that decision in the design history file 
required by Sec.  820.30(j) of this chapter.


Sec.  801.50  Labeling requirements for stand-alone software.

    (a) Stand-alone software that is not distributed in packaged form 
(e.g., when downloaded from a Web site) is deemed to meet the UDI 
labeling requirements of this subpart if it complies with the 
requirements of paragraph (b) of this section and conveys the version 
number in its production identifier.
    (b) Regardless of whether it is or is not distributed in packaged 
form, stand-alone software regulated as a medical device must provide 
its unique device identifier through either or both of the following:
    (1) An easily readable plain-text statement displayed whenever the 
software is started;
    (2) An easily readable plain-text statement displayed through a 
menu command (e.g., an ``About * * *'' command).
    (c) Stand-alone software that is distributed in both packaged form 
and in a form that is not packaged (e.g., when downloaded from a Web 
site) may be identified with the same device identifier.

0
5c. Effective December 23, 2013, add Sec.  801.57 to subpart B to read 
as follows:


Sec.  801.57  Discontinuation of legacy FDA identification numbers 
assigned to devices.

    (a) On the date your device must bear a unique device identifier 
(UDI) on its label, any National Health-Related Item Code (NHRIC) or 
National Drug Code (NDC) number assigned to that device is rescinded, 
and you may no longer provide an NHRIC or NDC number on the label of 
your device or on any device package.
    (b) If your device is not required to bear a UDI on its label, any 
NHRIC or NDC number assigned to that device is rescinded as of 
September 24, 2018, and beginning on that date, you may no longer 
provide an NHRIC or NDC number of the label of your device or on any 
device package.
    (c) A labeler who has been assigned an FDA labeler code to 
facilitate use of NHRIC or NDC numbers may continue to use that labeler 
code under a system for the issuance of UDIs, provided that--
    (1) Such use is consistent with the framework of the issuing agency 
that operates that system; and
    (2) No later than September 24, 2014, the labeler submits, and 
obtains FDA approval of, a request for continued use of the assigned 
labeler code. A request for continued use of an assigned labeler code 
must be submitted by email to: [email protected], or by correspondence 
to: UDI Regulatory Policy Support, Center for Devices and Radiological 
Health, Food and Drug Administration, Bldg. 66, Rm. 3303, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002.
    (d) Each request for continued use of an assigned labeler code must 
provide--
    (1) The name, mailing address, email address, and phone number of 
the labeler who is currently using the labeler code;
    (2) The owner/operator account identification used by the labeler 
to submit registration and listing information using FDA's Unified 
Registration and Listing System (FURLS).
    (3) The FDA labeler code that the labeler wants to continue using.

0
6. Revise Sec.  801.119 to read as follows:


Sec.  801.119  In vitro diagnostic products.

    A product intended for use in the diagnosis of disease and which is 
an in vitro diagnostic product as defined in Sec.  809.3(a) of this 
chapter shall be deemed to be in compliance with the requirements of 
this part and section 502(f)(1) of the Federal Food, Drug, and Cosmetic 
Act if it meets the requirements of subpart B of this part and the 
requirements of Sec.  809.10 of this chapter.

0
7. Amend Sec.  801.128 by redesignating paragraphs (f)(2) through 
(f)(7) as paragraphs (f)(3) through (f)(8), respectively, and by adding 
new paragraph (f)(2) to read as follows:


Sec.  801.128  Exceptions or alternatives to labeling requirements for 
medical devices held by the Strategic National Stockpile.

* * * * *
    (f) * * *
    (2) Subpart B of this part and part 830 of this chapter in its 
entirety;
* * * * *

PART 803--MEDICAL DEVICE REPORTING

0
8. The authority citation for 21 CFR part 803 continues to read as 
follows:

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

0
9. Amend Sec.  803.3 by alphabetically adding the following definitions 
to read as follows:


Sec.  803.3  How does FDA define the terms used in this part?

* * * * *
    Human cell, tissue, or cellular or tissue-based product (HCT/P) 
regulated as a device means an HCT/P as defined in Sec.  1271.3(d) of 
this chapter that does not meet the criteria in Sec.  1271.10(a) and 
that is also regulated as a device.
* * * * *
    Unique device identifier (UDI) means an identifier that adequately 
identifies a device through its distribution and use by meeting the 
requirements of Sec.  830.20 of this chapter. A unique device 
identifier is composed of:
    (1) A device identifier--a mandatory, fixed portion of a UDI that 
identifies the specific version or model of a device and the labeler of 
that device; and
    (2) A production identifier--a conditional, variable portion of a 
UDI that identifies one or more of the following when included on the 
label of the device:
    (i) The lot or batch within which a device was manufactured;
    (ii) The serial number of a specific device;
    (iii) The expiration date of a specific device;
    (iv) The date a specific device was manufactured.
    (v) For an HCT/P regulated as a device, the distinct identification 
code required by Sec.  1271.290(c) of this chapter.
* * * * *

0
10. Amend Sec.  803.32 by redesignating paragraphs (c)(6) through 
(c)(10) as paragraphs (c)(7) through (c)(11), respectively, and by 
adding new paragraph (c)(6) to read as follows:


Sec.  803.32  If I am a user facility, what information must I submit 
in my individual adverse event reports?

* * * * *
    (c) * * *
    (6) The unique device identifier (UDI) that appears on the device 
label or on the device package;
* * * * *

0
11. Amend Sec.  803.33 by redesignating paragraphs (a)(7)(iv) through 
(a)(7)(vi) as paragraphs (a)(7)(v) through (a)(7)(vii), respectively, 
and by adding new paragraph (a)(7)(iv) to read as follows:


Sec.  803.33  If I am a user facility, what must I include when I 
submit an annual report?

    (a) * * *
    (7) * * *
    (iv) The unique device identifier (UDI) that appears on the device 
label or on the device package;
* * * * *

0
12. Amend Sec.  803.42 by redesignating paragraphs (c)(6) through 
(c)(10) as paragraphs (c)(7) through (c)(11), respectively, and by 
adding new paragraph (c)(6) to read as follows:

[[Page 58821]]

Sec.  803.42  If I am an importer, what information must I submit in my 
individual adverse event reports?

* * * * *
    (c) * * *
    (6) The unique device identifier (UDI) that appears on the device 
label or on the device package;
* * * * *

0
13. Amend Sec.  803.52 by redesignating paragraphs (c)(6) through 
(c)(10) as paragraphs (c)(7) through (c)(11), respectively, and by 
adding new paragraph (c)(6) to read as follows:


Sec.  803.52  If I am a manufacturer, what information must I submit in 
my individual adverse event reports?

* * * * *
    (c) * * *
    (6) The unique device identifier (UDI) that appears on the device 
label or on the device package;
* * * * *

PART 806--MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS

0
14. The authority citation for 21 CFR part 806 continues to read as 
follows:

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

0
15. Amend Sec.  806.2 by redesignating paragraphs (f) through (l) as 
paragraphs (g) through (m), respectively, and by adding paragraphs (f) 
and (n) to read as follows:


Sec.  806.2  Definitions.

* * * * *
    (f) Human cell, tissue, or cellular or tissue-based product (HCT/P) 
regulated as a device means an HCT/P as defined in Sec.  1271.3(d) of 
this chapter that does not meet the criteria in Sec.  1271.10(a) and 
that is also regulated as a device.
* * * * *
    (n) Unique device identifier (UDI) means an identifier that 
adequately identifies a device through its distribution and use by 
meeting the requirements of Sec.  830.20 of this chapter. A UDI is 
composed of:
    (1) A device identifier--a mandatory, fixed portion of a UDI that 
identifies the specific version or model of a device and the labeler of 
that device; and
    (2) A production identifier--a conditional, variable portion of a 
UDI that identifies one or more of the following when included on the 
label of the device:
    (i) The lot or batch within which a device was manufactured;
    (ii) The serial number of a specific device;
    (iii) The expiration date of a specific device;
    (iv) The date a specific device was manufactured.
    (v) For an HCT/P regulated as a device, the distinct identification 
code required by Sec.  1271.290(c) of this chapter.

0
16. Amend Sec.  806.10 by revising paragraph (c)(5) to read as follows:


Sec.  806.10  Reports of corrections and removals.

* * * * *
    (c) * * *
    (5) The unique device identifier (UDI) that appears on the device 
label or on the device package, or the device identifier, universal 
product code (UPC), model, catalog, or code number of the device and 
the manufacturing lot or serial number of the device or other 
identification number.
* * * * *
0
17. Amend Sec.  806.20 by revising paragraph (b)(2) to read as follows:


Sec.  806.20  Records of corrections and removals not required to be 
reported.

* * * * *
    (b) * * *
    (2) The unique device identifier (UDI) of the device, or the device 
identifier, universal product code (UPC), model, catalog, or code 
number of the device and the manufacturing lot or serial number of the 
device or other identification number.
* * * * *

PART 810--MEDICAL DEVICE RECALL AUTHORITY

0
18. The authority citation for 21 CFR part 810 is revised to read as 
follows:

    Authority: 21 U.S.C. 321, 331, 332, 333, 334, 351, 352, 355, 
360h, 360i, 371, 374, 375.

0
19. Amend Sec.  810.2 by redesignating paragraphs (h) through (k) as 
paragraphs (i) through (l), respectively, and by adding paragraphs (h) 
and (m) to read as follows:


Sec.  810.2  Definitions.

* * * * *
    (h) Human cell, tissue, or cellular or tissue-based product (HCT/P) 
regulated as a device means an HCT/P as defined in Sec.  1271.3(d) of 
this chapter that does not meet the criteria in Sec.  1271.10(a) and 
that is also regulated as a device.
* * * * *
    (m) Unique device identifier (UDI) means an identifier that 
adequately identifies a device through its distribution and use by 
meeting the requirements of Sec.  830.20 of this chapter. A unique 
device identifier is composed of:
    (1) A device identifier--a mandatory, fixed portion of a UDI that 
identifies the specific version or model of a device and the labeler of 
that device; and
    (2) A production identifier--a conditional, variable portion of a 
UDI that identifies one or more of the following when included on the 
label of the device:
    (i) The lot or batch within which a device was manufactured;
    (ii) The serial number of a specific device;
    (iii) The expiration date of a specific device;
    (iv) The date a specific device was manufactured.
    (v) For an HCT/P regulated as a device, the distinct identification 
code required by Sec.  1271.290(c) of this chapter.

0
20. Amend Sec.  810.10 by removing the word ``and'' at the end of 
paragraph (b)(2)(iii) and by adding paragraph (b)(2)(v) to read as 
follows:


Sec.  810.10  Cease distribution and notification order.

* * * * *
    (b) * * *
    (2) * * *
    (v) The unique device identifier (UDI) that appears on the device 
label or on the device package; and
* * * * *

PART 814--PREMARKET APPROVAL OF MEDICAL DEVICES

0
21. The authority citation for 21 CFR part 814 continues to read as 
follows:

    Authority:  21 U.S.C. 351, 352, 353, 360c-360j, 371, 372, 373, 
374, 375, 379, 379e, 381.

0
22. Amend Sec.  814.3 by adding new paragraphs (p), (q), and (r) to 
read as follows:


Sec.  814.3  Definitions.

* * * * *
    (p) Human cell, tissue, or cellular or tissue-based product (HCT/P) 
regulated as a device means an HCT/P as defined in Sec.  1271.3(d) of 
this chapter that does not meet the criteria in Sec.  1271.10(a) and 
that is also regulated as a device.
    (q) Unique device identifier (UDI) means an identifier that 
adequately identifies a device through its distribution and use by 
meeting the requirements of Sec.  830.20 of this chapter. A unique 
device identifier is composed of:
    (1) A device identifier--a mandatory, fixed portion of a UDI that 
identifies the specific version or model of a device and the labeler of 
that device; and
    (2) A production identifier--a conditional, variable portion of a 
UDI that identifies one or more of the following when included on the 
label of the device:

[[Page 58822]]

    (i) The lot or batch within which a device was manufactured;
    (ii) The serial number of a specific device;
    (iii) The expiration date of a specific device;
    (iv) The date a specific device was manufactured.
    (v) For an HCT/P regulated as a device, the distinct identification 
code required by Sec.  1271.290(c) of this chapter.
    (r) Universal product code (UPC) means the product identifier used 
to identify an item sold at retail in the United States.

0
23. Amend Sec.  814.84 by adding new paragraph (b)(4) to read as 
follows:


Sec.  814.84  Reports.

* * * * *
    (b) * * *
    (4) Identify each device identifier currently in use for the 
device, and each device identifier for the device that has been 
discontinued since the previous periodic report. It is not necessary to 
identify any device identifier discontinued prior to December 23, 2013.

PART 820--QUALITY SYSTEM REGULATION

0
24. The authority citation for 21 CFR part 820 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 352, 360, 360c, 360d, 360e, 360h, 
360i, 360j, 360l, 371, 374, 381, 383; 42 U.S.C. 216, 262, 263a, 264.

0
25. Amend Sec.  820.3 by adding new paragraphs (bb), (cc), and (dd) to 
read as follows:


Sec.  820.3  Definitions.

* * * * *
    (bb) Human cell, tissue, or cellular or tissue-based product (HCT/
P) regulated as a device means an HCT/P as defined in Sec.  1271.3(d) 
of this chapter that does not meet the criteria in Sec.  1271.10(a) and 
that is also regulated as a device.
    (cc) Unique device identifier (UDI) means an identifier that 
adequately identifies a device through its distribution and use by 
meeting the requirements of Sec.  830.20 of this chapter. A unique 
device identifier is composed of:
    (1) A device identifier--a mandatory, fixed portion of a UDI that 
identifies the specific version or model of a device and the labeler of 
that device; and
    (2) A production identifier--a conditional, variable portion of a 
UDI that identifies one or more of the following when included on the 
label of the device:
    (i) The lot or batch within which a device was manufactured;
    (ii) The serial number of a specific device;
    (iii) The expiration date of a specific device;
    (iv) The date a specific device was manufactured.
    (v) For an HCT/P regulated as a device, the distinct identification 
code required by Sec.  1271.290(c) of this chapter.
    (dd) Universal product code (UPC) means the product identifier used 
to identify an item sold at retail in the United States.

0
26. Amend Sec.  820.120 by revising the first sentence of paragraph (b) 
to read as follows:


Sec.  820.120  Device labeling.

* * * * *
    (b) Labeling inspection. Labeling shall not be released for storage 
or use until a designated individual(s) has examined the labeling for 
accuracy including, where applicable, the correct unique device 
identifier (UDI) or universal product code (UPC), expiration date, 
control number, storage instructions, handling instructions, and any 
additional processing instructions. * * *
* * * * *

0
27. Amend Sec.  820.184 by revising paragraph (f) to read as follows:


Sec.  820.184  Device history record.

* * * * *
    (f) Any unique device identifier (UDI) or universal product code 
(UPC), and any other device identification(s) and control number(s) 
used.

0
28. Amend Sec.  820.198 by revising paragraph (e)(3) to read as 
follows:


Sec.  820.198  Complaint files.

* * * * *
    (e) * * *
    (3) Any unique device identifier (UDI) or universal product code 
(UPC), and any other device identification(s) and control number(s) 
used;
* * * * *

0
29. Amend Sec.  820.200 by revising paragraph (d)(2) to read as 
follows:


Sec.  820.200  Servicing.

* * * * *
    (d) * * *
    (2) Any unique device identifier (UDI) or universal product code 
(UPC), and any other device identification(s) and control number(s) 
used;
* * * * *

PART 821--MEDICAL DEVICE TRACKING REQUIREMENTS

0
30. The authority citation for 21 CFR part 821 continues to read as 
follows:

    Authority:  21 U.S.C. 331, 351, 352, 360, 360e, 360h, 360i, 371, 
374.


0
31. Amend Sec.  821.3 by adding new paragraphs (n) and (o) to read as 
follows:


Sec.  821.3  Definitions.

* * * * *
    (n) Human cell, tissue, or cellular or tissue-based product (HCT/P) 
regulated as a device means an HCT/P as defined in Sec.  1271.3(d) of 
this chapter that does not meet the criteria in Sec.  1271.10(a) and 
that is also regulated as a device.
    (o) Unique device identifier (UDI) means an identifier that 
adequately identifies a device through its distribution and use by 
meeting the requirements of Sec.  830.20 of this chapter. A unique 
device identifier is composed of:
    (1) A device identifier--a mandatory, fixed portion of a UDI that 
identifies the specific version or model of a device and the labeler of 
that device; and
    (2) A production identifier--a conditional, variable portion of a 
UDI that identifies one or more of the following when included on the 
label of the device:
    (i) The lot or batch within which a device was manufactured;
    (ii) The serial number of a specific device;
    (iii) The expiration date of a specific device;
    (iv) The date a specific device was manufactured.
    (v) For an HCT/P regulated as a device, the distinct identification 
code required by Sec.  1271.290(c) of this chapter.

0
32. Amend Sec.  821.25 by revising paragraphs (a)(2)(i) and (a)(3)(i) 
to read as follows:


Sec.  821.25  Device tracking system and content requirements: 
manufacturer requirements.

    (a) * * *
    (2) * * *
    (i) The unique device identifier (UDI), lot number, batch number, 
model number, or serial number of the device or other identifier 
necessary to provide for effective tracking of the devices;
* * * * *
    (3) * * *
    (i) The unique device identifier (UDI), lot number, batch number, 
model number, or serial number of the device or other identifier 
necessary to provide for effective tracking of the devices;
* * * * *

0
33. Amend Sec.  821.30 by revising paragraphs (a)(2), (b)(2), and 
(c)(1)(i) to read as follows:

[[Page 58823]]

Sec.  821.30  Tracking obligations of persons other than device 
manufacturers: distributor requirements.

    (a) * * *
    (2) The unique device identifier (UDI), lot number, batch number, 
model number, or serial number of the device or other identifier used 
by the manufacturer to track the device;
* * * * *
    (b) * * *
    (2) The unique device identifier (UDI), lot number, batch number, 
model number, or serial number of the device or other identifier used 
by the manufacturer to track the device;
* * * * *
    (c) * * *
    (1) * * *
    (i) The unique device identifier (UDI), lot number, batch number, 
model number, or serial number of the device or other identifier used 
by the manufacturer to track the device;
* * * * *

PART 822--POSTMARKET SURVEILLANCE

0
34. The authority citation for 21 CFR part 822 continues to read as 
follows:

    Authority: 21 U.S.C. 331, 352, 360i, 360l, 371, 374.


0
35. Amend Sec.  822.3 by redesignating paragraphs (e) through (m) as 
paragraphs (f) through (n), respectively, and by adding new paragraphs 
(e) and (o) to read as follows:


Sec.  822.3  How do you define the terms used in this part?

* * * * *
    (e) Human cell, tissue, or cellular or tissue-based product (HCT/P) 
regulated as a device means an HCT/P as defined in Sec.  1271.3(d) of 
this chapter that does not meet the criteria in Sec.  1271.10(a) and 
that is also regulated as a device.
* * * * *
    (o) Unique device identifier (UDI) means an identifier that 
adequately identifies a device through its distribution and use by 
meeting the requirements of Sec.  830.20 of this chapter. A UDI is 
composed of:
    (1) A device identifier--a mandatory, fixed portion of a UDI that 
identifies the specific version or model of a device and the labeler of 
that device; and
    (2) A production identifier--a conditional, variable portion of a 
UDI that identifies one or more of the following when included on the 
label of the device:
    (i) The lot or batch within which a device was manufactured;
    (ii) The serial number of a specific device;
    (iii) The expiration date of a specific device;
    (iv) The date a specific device was manufactured.
    (v) For an HCT/P regulated as a device, the distinct identification 
code required by Sec.  1271.290(c) of this chapter.

0
36. Amend Sec.  822.9 by revising paragraph (a)(4) to read as follows:


Sec.  822.9  What must I include in my submission?

* * * * *
    (a) * * *
    (4) Premarket application/submission number and device identifiers 
for your device;
* * * * *

0
37a. Effective October 24, 2013, add new part 830 to read as follows:

PART 830--UNIQUE DEVICE IDENTIFICATION

Subpart A--[Reserved]
Subpart B--Requirements for a Unique Device Identifier
Sec.
830.10 Incorporation by reference.
Subpart C--FDA Accreditation of an Issuing Agency
830.100 FDA accreditation of an issuing agency.
830.110 Application for accreditation as an issuing agency.
830.120 Responsibilities of an FDA-accredited issuing agency.
830.130 Suspension or revocation of the accreditation of an issuing 
agency.
Subpart D--[Reserved]
Subpart E--[Reserved]

    Authority:  21 U.S.C. 321, 331, 352, 353, 360, 360d, 360i, 360j, 
371.

Subpart A--[Reserved]

Subpart B--Requirements for a Unique Device Identifier


Sec.  830.10  Incorporation by reference.

    (a) Certain material is incorporated by reference into this part 
with the approval of the Director of the Federal Register in accordance 
with 5 U.S.C. 552(a) and 1 CFR part 51. To enforce any edition other 
than that specified in this section, the Food and Drug Administration 
must publish notice of change in the Federal Register and the material 
must be available to the public. All approved material is available for 
inspection at the Division of Dockets Management (HFA-305), Food and 
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, 
301-827-6860, and is available from the source listed in paragraph (b) 
of this section. Copies are also available for purchase from the 
American National Standards Institute (ANSI), mailing address: ANSI, 
Attn: Customer Service Department, 25 West 43rd St., 4th floor, New 
York, NY 10036, phone: 212-642-4980, and may be ordered online at 
http://webstore.ansi.org/. The material is also available for 
inspection at the National Archives and Records Administration (NARA). 
For information on the availability of this material at NARA, call 202-
741-6030 or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
    (b) International Organization for Standardization (ISO), mailing 
address: ISO, Attn: ISO Central Secretariat, 1, ch. de la Voie-Creuse, 
Case postale 56, CH-1211 Geneva 20, Switzerland, phone (dialing from 
the United States): 011-41-22-749-0111, and may be ordered online at 
http://www.standardsinfo.net.
    (1) ISO/IEC 646:1991(E), Information technology--ISO 7-bit coded 
character set for information interchange (third edition; December 15, 
1991), into Sec. Sec.  830.20(c) and 830.100(b);
    (2) ISO/IEC 15459-2:2006(E), Information technology--Unique 
identifiers--Part 2: Registration procedures (second edition; March 1, 
2006), into Sec. Sec.  830.20(b) and 830.100(b);
    (3) ISO/IEC 15459-4:2008(E), Information technology--Unique 
identifiers--Part 4: Individual items (second edition; July 15, 2008), 
into Sec. Sec.  830.20(b) and 830.100(b);
    (4) ISO/IEC 15459-6:2007(E), Information technology--Unique 
identifiers--Part 6: Unique identifier for product groupings (first 
edition; June 15, 2007), into Sec. Sec.  830.20(b) and 830.100(b).

Subpart C--FDA Accreditation of an Issuing Agency


Sec.  830.100  FDA accreditation of an issuing agency.

    (a) Eligibility. A private organization may apply for accreditation 
as an issuing agency.
    (b) Accreditation criteria. FDA may accredit an organization as an 
issuing agency, if the system it will operate:
    (1) Will employ unique device identifiers (UDIs) that meet the 
requirements of this part to adequately identify a device through its 
distribution and use;
    (2) Conforms to each of the following international standards:
    (i) ISO/IEC 15459-2, which is incorporated by reference at Sec.  
830.10;
    (ii) ISO/IEC 15459-4, which is incorporated by reference at Sec.  
830.10;
    (iii) ISO/IEC 15459-6, which is incorporated by reference at Sec.  
830.10.

[[Page 58824]]

    (3) Uses only characters and numbers from the invariant character 
set of ISO/IEC 646, which is incorporated by reference at Sec.  830.10.
    (4) Will be available to all users according to a single set of 
consistent, fair, and reasonable terms and conditions.
    (5) Will protect against conflicts of interest between the issuing 
agency (and its officers, employees, and other agents) and labelers 
(and their officers, employees, and other agents) seeking to use UDIs 
that may impede the applicant's ability to independently operate a fair 
and neutral identifier system.


Sec.  830.110  Application for accreditation as an issuing agency.

    (a) Application for initial accreditation. (1) An applicant seeking 
initial FDA accreditation as an issuing agency shall notify FDA of its 
desire to be accredited by sending a notification by email to 
[email protected], or by correspondence to: UDI Regulatory Policy 
Support, Center for Devices and Radiological Health, Food and Drug 
Administration, Bldg. 66, Rm. 3303, 10903 New Hampshire Ave., Silver 
Spring, MD 20993-0002.
    (2) FDA will provide the applicant with additional information to 
aid in submission of an application for approval as an issuing agency, 
together with an email address for submission of an application.
    (3) The applicant shall furnish to FDA, via email to the email 
address provided in paragraph (a)(1) of this section, an application 
containing the following information, materials, and supporting 
documentation:
    (i) Name, address, and phone number of the applicant;
    (ii) Detailed descriptions of any standards or criteria the 
applicant will apply to participating labelers;
    (iii) A detailed description of the guidelines that govern 
assignment of a unique device identifier (UDI) to a device;
    (iv) A detailed description of the review and decisionmaking 
process the applicant will apply when determining whether a particular 
labeler may use the applicant's UDI system, including:
    (A) Copies of the application forms, guidelines, instructions, and 
other materials the applicant will send to medical device labelers who 
wish to use the applicant's unique device identification system;
    (B) Policies and procedures for notifying a labeler of deficiencies 
in its use of UDIs;
    (C) Procedures for monitoring a labeler's correction of 
deficiencies in its use of UDIs;
    (D) Policies and procedures for suspending or revoking a labeler's 
use of the applicant's UDI system, including any appeals process.
    (v) Description of the applicant's electronic data management 
system with respect to its review and decision processes and the 
applicant's ability to provide electronic data in a format compatible 
with FDA data systems;
    (vi) Fee schedules, if any, together with an explanation of any fee 
waivers or reductions that are available;
    (vii) Detailed information regarding any financial or other 
relationship between the applicant and any labeler(s) or governmental 
entity(ies); and
    (viii) Other information required by FDA to clarify the application 
for accreditation.
    (b) Application for renewal of accreditation. An accredited issuing 
agency that intends to continue to serve as an issuing agency beyond 
its current term shall apply to FDA for renewal or notify FDA of its 
plans not to apply for renewal in accordance with the following 
procedures and schedule:
    (1) At least 9 months before the date of expiration of its 
accreditation, an issuing agency shall inform FDA, at the address given 
in paragraph (a)(1) of this section, of its intent to seek renewal.
    (2) FDA will notify the issuing agency of the relevant information, 
materials, and supporting documentation that we will require the 
issuing agency to submit as part of the renewal procedure. We will 
tailor these requirements to reflect our experience with the issuing 
agency during the current and any prior period of accreditation. We 
will limit our request to the types of the information required by 
paragraph (a)(3) of this section, and we will require less information 
if experience shows that we need only a subset of that information.
    (3) At least 6 months before the date of expiration of its 
accreditation, an issuing agency shall furnish to FDA, at the email 
address we provide, a copy of a renewal application containing the 
information, materials, and supporting documentation requested by FDA 
in accordance with paragraph (b)(2) of this section.
    (4) Any issuing agency that does not plan to renew its 
accreditation shall so notify FDA at the address given in paragraph 
(a)(1) of this section at least 9 months before the expiration of the 
issuing agency's term of accreditation and shall include a description 
of its plans for allowing continued use of UDIs issued prior to the 
expiration of the current term of accreditation.
    (c) FDA action on an application for initial or renewal 
accreditation. (1) FDA will conduct a review and evaluation to 
determine whether the applicant meets the requirements of this subpart 
and whether the UDI system proposed by the applicant will meet the 
requirements of this subpart.
    (2) Within 60 days of receipt of an application for accreditation, 
FDA will notify the applicant of any deficiencies in its application 
and will request correction of those deficiencies within 60 days. The 
applicant may request an extension if it needs additional time to 
correct deficiencies in its application. If the deficiencies are not 
resolved to FDA's satisfaction within the specified time period, the 
application for accreditation as an issuing agency may be denied.
    (3) FDA shall notify the applicant whether the application for 
accreditation has been granted or denied. That notification shall list 
any conditions of approval or state the reasons for denial.
    (4) If FDA denies an application, we will advise the applicant of 
the circumstances under which a denied application may be resubmitted.
    (5) If FDA does not reach a final decision on a renewal application 
before the expiration of an issuing agency's current accreditation, the 
approval will be deemed extended until FDA reaches a final decision on 
the application.
    (d) Relinquishment of accreditation. If an issuing agency decides 
to relinquish its accreditation before expiration of the current term 
of accreditation, it shall submit a letter of such intent to FDA, at 
the address provided in paragraph (a)(1) of this section, at least 9 
months before relinquishing its accreditation.
    (e) Notice of termination of accreditation. An issuing agency that 
does not apply for renewal of its accreditation, is denied renewal of 
accreditation by FDA, or relinquishes its accreditation and duties 
before expiration of the current term of accreditation, shall notify 
all labelers that are using the issuing agency's UDI system, in a 
manner and time period approved by FDA, of the date that the issuing 
agency will cease to serve as an FDA-accredited issuing agency.
    (f) Term of accreditation. The initial term of accreditation for an 
issuing agency shall be for a period of 3 years. An issuing agency's 
term of accreditation may be periodically renewed for a period of 7 
years.


Sec.  830.120  Responsibilities of an FDA-accredited issuing agency.

    To maintain its accreditation, an issuing agency must:
    (a) Operate a system for assignment of unique device identifiers 
(UDIs) that meets the requirements of Sec.  830.20;

[[Page 58825]]

    (b) Make available information concerning its system for the 
assignment of UDIs;
    (c) Maintain a list of labelers that use its system for the 
assignment of UDIs and provide FDA a copy of such list in electronic 
form by December 31 of each year;
    (d) Upon request, provide FDA with information concerning a labeler 
that is employing the issuing agency's system for assignment of UDIs; 
and
    (e) Remain in compliance with the eligibility and accreditation 
criteria set forth in Sec.  830.100.


Sec.  830.130  Suspension or revocation of the accreditation of an 
issuing agency.

    FDA may suspend or revoke the accreditation of an issuing agency if 
FDA finds, after providing the issuing agency with notice and 
opportunity for an informal hearing in accordance with part 16 of this 
chapter, that the issuing agency or any officer, employee, or other 
agent of the issuing agency:
    (a) Has been guilty of misrepresentation or failure to disclose 
required information in obtaining accreditation;
    (b) Has failed to fulfill the responsibilities outlined in Sec.  
830.120;
    (c) Has failed to protect against conflicts of interest that may 
impede the issuing agency's ability to independently operate a fair and 
neutral identifier system;
    (d) In the operation of the issuing agency, has engaged in any 
anticompetitive activity to restrain trade; or
    (e) Has violated or aided and abetted in the violation of any 
regulation issued under section 510(e) or section 519(f) of the Federal 
Food, Drug, and Cosmetic Act.

Subpart D--[Reserved]

Subpart E--[Reserved]

0
37b. Effective December 23, 2013, add subpart A to part 830 to read as 
follows:

Subpart A--General Provisions


Sec.  830.3  Definitions.

    As used in this part:
    Automatic identification and data capture (AIDC) means any 
technology that conveys the unique device identifier or the device 
identifier of a device in a form that can be entered into an electronic 
patient record or other computer system via an automated process.
    Center Director means the Director of the Center for Devices and 
Radiological Health or the Director of the Center for Biologics 
Evaluation and Research, depending on which Center has been assigned 
lead responsibility for the device.
    Device package means a package that contains a fixed quantity of a 
particular version or model of a device.
    Expiration date means the date by which the label of a device 
states the device must or should be used.
    FDA, we, or us means the Food and Drug Administration.
    Federal Food, Drug, and Cosmetic Act means 21 U.S.C. 321 et seq., 
as amended.
    Finished device means any device or accessory to any device that is 
suitable for use or capable of functioning.
    Global Unique Device Identification Database (GUDID) means the 
database that serves as a repository of information to facilitate the 
identification of medical devices through their distribution and use.
    Human cell, tissue, or cellular or tissue-based product (HCT/P) 
regulated as a device means an HCT/P as defined in Sec.  1271.3(d) of 
this chapter that does not meet the criteria in Sec.  1271.10(a) and 
that is also regulated as a device.
    Issuing agency means an organization accredited by FDA to operate a 
system for the issuance of unique device identifiers.
    Label has the meaning set forth in section 201(k) of the Federal 
Food, Drug, and Cosmetic Act.
    Labeler means:
    (1) Any person who causes a label to be applied to a device with 
the intent that the device will be commercially distributed without any 
subsequent replacement or modification of the label; and
    (2) Any person who causes the label of a device to be replaced or 
modified with the intent that the device will be commercially 
distributed without any subsequent replacement or modification of the 
label, except that the addition of the name of, and contact information 
for, a person who distributes the device, without making any other 
changes to the label, is not a modification for the purposes of 
determining whether a person is a labeler.
    Lot or batch means one finished device or more that consist of a 
single type, model, class, size, composition, or software version that 
are manufactured under essentially the same conditions and that are 
intended to have uniform characteristics and quality within specified 
limits.
    Shipping container means a container used during the shipment or 
transportation of devices, and whose contents may vary from one 
shipment to another.
    Small business means a medical device manufacturer with 500 or 
fewer employees, or a medical device relabeler or repackager with 100 
or fewer employees.
    Specification means any requirement with which a device must 
conform.
    Unique device identifier (UDI) means an identifier that adequately 
identifies a device through its distribution and use by meeting the 
requirements of Sec.  830.20. A UDI is composed of:
    (1) A device identifier--a mandatory, fixed portion of a UDI that 
identifies the specific version or model of a device and the labeler of 
that device; and
    (2) A production identifier--a conditional, variable portion of a 
UDI that identifies one or more of the following when included on the 
label of the device:
    (i) The lot or batch within which a device was manufactured;
    (ii) The serial number of a specific device;
    (iii) The expiration date of a specific device;
    (iv) The date a specific device was manufactured.
    (v) For an HCT/P regulated as a device, the distinct identification 
code required by Sec.  1271.290(c) of this chapter.
    Universal product code (UPC) means the product identifier used to 
identify an item sold at retail in the United States.
    Version or model means all devices that have specifications, 
performance, size, and composition, within limits set by the labeler.

0
37c. Effective December 23, 2013, add Sec. Sec.  830.20, 830.40, 
830.50, and 830.60 to subpart B to read as follows:

Sec.
830.20 Requirements for a unique device identifier.
830.40 Use and discontinuation of a device identifier.
830.50 Changes that require use of a new device identifier.
830.60 Relabeling of a device that is required to bear a unique 
device identifier.


Sec.  830.20  Requirements for a unique device identifier.

    A unique device identifier (UDI) must:
    (a) Be issued under a system operated by FDA or an FDA-accredited 
issuing agency;
    (b) Conform to each of the following international standards:
    (1) ISO/IEC 15459-2, which is incorporated by reference at Sec.  
830.10;
    (2) ISO/IEC 15459-4, which is incorporated by reference at Sec.  
830.10; and

[[Page 58826]]

    (3) ISO/IEC 15459-6, which is incorporated by reference at Sec.  
830.10.
    (c) Use only characters and numbers from the invariant character 
set of ISO/IEC 646, which is incorporated by reference at Sec.  830.10.


Sec.  830.40  Use and discontinuation of a device identifier.

    (a) Only one device identifier from any particular system for the 
issuance of unique device identifiers (UDIs) may be used to identify a 
particular version or model of a device. A particular version or model 
may be identified by UDIs from two or more systems for the issuance of 
UDIs.
    (b) A device identifier shall be used to identify only one version 
or model.
    (c) In the event that a version or model of a device is 
discontinued, its device identifier may not be reassigned to another 
device. If a discontinued version or model is re-introduced and no 
changes have been made that would require the use of a new device 
identifier, the device identifier that was previously in use may be 
used to identify the device.
    (d) In the event that an issuing agency relinquishes or does not 
renew its accreditation, you may continue to use a previously issued 
UDI until such time as Sec.  830.50 requires you to assign a new device 
identifier.


Sec.  830.50  Changes that require use of a new device identifier.

    (a) Whenever you make a change to a device that is required to bear 
a unique device identifier (UDI) on its label, and the change results 
in a new version or model, you must assign a new device identifier to 
the new version or model.
    (b) Whenever you create a new device package, you must assign a new 
device identifier to the new device package.


Sec.  830.60  Relabeling of a device that is required to bear a unique 
device identifier.

    If you relabel a device that is required to bear a unique device 
identifier (UDI), you must:
    (a) Assign a new device identifier to the device, and
    (b) Keep a record showing the relationship of the prior device 
identifier to your new device identifier.

0
37d. Effective December 23, 2013, add subparts D and E to part 830 to 
read as follows:
Subpart D--FDA as an Issuing Agency
830.200 When FDA will act as an issuing agency.
830.210 Eligibility for use of FDA as an issuing agency.
830.220 Termination of FDA service as an issuing agency.
Subpart E--Global Unique Device Identification Database
830.300 Devices subject to device identification data submission 
requirements.
830.310 Information required for unique device identification.
830.320 Submission of unique device identification information.
830.330 Times for submission of unique device identification 
information.
830.340 Voluntary submission of ancillary device identification 
information.
830.350 Correction of information submitted to the Global Unique 
Device Identification Database.
830.360 Records to be maintained by the labeler.

Subpart D--FDA as an Issuing Agency


Sec.  830.200  When FDA will act as an issuing agency.

    (a) During any period where there is no accredited issuing agency, 
FDA will act as an issuing agency.
    (b) If FDA determines that a significant number of small businesses 
would be substantially and adversely affected by the fees required by 
all accredited issuing agencies, FDA will act as an issuing agency.
    (c) FDA may, in its discretion, act as an issuing agency if we 
determine it is necessary for us to do so to ensure the continuity or 
the effectiveness of the system for the identification of medical 
devices.
    (d) FDA may, in its discretion, act as an issuing agency if we 
determine it is appropriate for us to do so in order to facilitate or 
implement an alternative granted under Sec.  801.55 of this chapter.


Sec.  830.210  Eligibility for use of FDA as an issuing agency.

    When FDA acts as an issuing agency, any labeler will be permitted 
to use FDA's unique device identification system, regardless of whether 
the labeler is considered a small business.


Sec.  830.220  Termination of FDA service as an issuing agency.

    (a) FDA may end our services as an issuing agency if we determine 
that the conditions that prompted us to act no longer exist and that 
ending our services would not be likely to lead to a return of the 
conditions that prompted us to act.
    (b) If FDA has ended our services as an issuing agency, a labeler 
may continue to use a device identifier assigned under FDA's unique 
device identification system until such time as Sec.  830.50 requires 
the use of a new device identifier.

Subpart E--Global Unique Device Identification Database


Sec.  830.300  Devices subject to device identification data submission 
requirements.

    (a) In general. The labeler of a device must provide the 
information required by this subpart for each version or model required 
to bear a unique device identifier (UDI).
    (b) Voluntary submission of information. If a labeler voluntarily 
includes a UDI on the label of a device under Sec.  801.40, the labeler 
may also voluntarily submit information concerning that device under 
this part.
    (c) Exclusions. FDA may reject or remove any device identification 
data where:
    (1) The device identifier submitted does not conform to Sec.  
830.20;
    (2) The information concerns a device that is neither manufactured 
in the United States nor in interstate commerce in the United States,
    (3) The information concerns a product that FDA determines is not a 
device or a combination product that includes a device constituent 
part,
    (4) The information concerns a device or a combination product that 
requires, but does not have, FDA premarket approval, licensure, or 
clearance;
    (5) A device that FDA has banned under section 516 of the Federal 
Food, Drug, and Cosmetic Act; or
    (6) FDA has suspended the accreditation of the issuing agency that 
operates the system used by the labeler.


Sec.  830.310  Information required for unique device identification.

    The contact for device identification designated under Sec.  
830.320(a) shall provide FDA with the following information concerning 
each version or model of a device required to bear a unique device 
identifier (UDI) on its label:
    (a) Concerning the labeler:
    (1) The name of the labeler;
    (2) A telephone number or email address that will allow FDA to 
communicate with the contact for device identification designated under 
Sec.  830.320(a); and
    (3) The name of each issuing agency whose system is used by the 
labeler to assign UDIs used by the labeler.
    (b) Concerning each version or model of a device with a UDI on its 
label:
    (1) The device identifier portion of the UDI assigned to the 
version or model;
    (2) When reporting a substitution of a new device identifier that 
will be used in lieu of a previously reported identifier, the device 
identifier that was previously assigned to the version or model;

[[Page 58827]]

    (3) If Sec.  801.45 of this chapter requires the device to bear a 
UDI as a permanent marking on the device itself, either:
    (i) A statement that the device identifier that appears as a 
permanent marking on the device is identical to that reported under 
paragraph (b)(1) of this section, or
    (ii) The device identifier portion of the UDI that appears as a 
permanent marking on the device;
    (4) The proprietary, trade, or brand name of the device as it 
appears on the label of the device;
    (5) Any version or model number or similar reference that appears 
on the label of the device;
    (6) If the device is labeled as sterile, a statement to that 
effect;
    (7) If the device is labeled as containing natural rubber latex 
that contacts humans, or is labeled as having packaging containing 
natural rubber latex that contacts humans, as described by Sec. Sec.  
801.437(b)(1), 801.437(b)(3), and 801.437(f) of this chapter, a 
statement to that effect;
    (8) Whether a patient may be safely exposed to magnetic resonance 
imaging, nuclear magnetic resonance imaging, or magnetic resonance 
tomography while using the device, or while the device is implanted in 
patient.
    (9) If the device is available in more than one size, the size of 
the particular version or model, together with the unit of measure, as 
it appears on the label of the device;
    (10) The type of production identifiers that appear on the label of 
the device;
    (11) The FDA premarket submission number of a cleared or approved 
device, or a statement that FDA has by regulation exempted the device 
from premarket notification;
    (12) The FDA listing number assigned to the device;
    (13) The Global Medical Device Nomenclature (GMDN) term or code for 
the device;
    (14) The total number of individual devices contained in the device 
package.


Sec.  830.320  Submission of unique device identification information.

    (a) Designation of contact for device identification. Each labeler 
must designate an individual to serve as the point of contact with FDA 
on matters relating to the identification of medical devices marketed 
by the labeler. The contact for device information is responsible for 
ensuring FDA is provided with all information required by this part. 
The contact for device information may authorize an issuing agency or 
any other person to provide information to FDA on behalf of the 
labeler.
    (b) Information shall be submitted via electronic means. All 
information required by this subpart shall be submitted electronically 
to FDA's Global Unique Device Identification Database (GUDID) in a 
format that we can process, review, and archive, unless the labeler has 
obtained a waiver from electronic submission of unique device 
identifier (UDI) data.
    (c) Waiver from electronic submission. (1) A labeler may request a 
waiver from electronic submission of UDI data by submitting a letter 
addressed to the appropriate Center Director explaining why electronic 
submission is not technologically feasible; send the request by email 
to: [email protected], or by correspondence to: UDI Regulatory Policy 
Support, Center for Devices and Radiological Health, Food and Drug 
Administration, Bldg. 66, Rm. 3303, 10903 New Hampshire Ave., Silver 
Spring, MD 20993-0002.
    (2) If the establishment where the labeler is located has obtained 
a waiver from electronic submission of registration and listing 
information under section 510(p) of the Federal Food, Drug, and 
Cosmetic Act, the labeler is deemed to have a waiver from electronic 
submission of UDI data.
    (3) A labeler that has a waiver from electronic submission of UDI 
data must send a letter containing all of the information required by 
Sec.  830.310, as well as any ancillary information permitted to be 
submitted under Sec.  830.340 that the labeler wishes to submit, within 
the time permitted by Sec.  830.330, addressed to: UDI Regulatory 
Policy Support, Center for Devices and Radiological Health, Food and 
Drug Administration, Bldg. 66, Rm. 3303, 10903 New Hampshire Ave., 
Silver Spring, MD 20993-0002.


Sec.  830.330  Times for submission of unique device identification 
information.

    (a) The labeler shall submit to FDA the information required by 
Sec.  830.310 no later than the date the label of the device must bear 
a unique device identifier under Sec.  801.20 of this chapter.
    (b) The labeler of a device shall submit to FDA an update to the 
information required by Sec.  830.310 whenever the information changes. 
The updated information must be submitted no later than the date a 
device is first labeled with the changed information. If the 
information does not appear on the label of a device, the updated 
information must be submitted within 10 business days of the change.


Sec.  830.340  Voluntary submission of ancillary device identification 
information.

    (a) You may not submit any information to the Global Unique Device 
Identification Database (GUDID) other than that specified by Sec.  
830.310, except where FDA acts to permit the submission of specified 
additional types of information, termed ancillary information.
    (b) FDA will provide information through the FDA Web site at http://www.fda.gov/udi/ concerning the types of ancillary information that 
may be submitted to the GUDID.
    (c) FDA may periodically change the types of ancillary information 
that may be submitted to the GUDID. We will announce any change on the 
FDA Web site at http://www.fda.gov/udi/ at least 60 days before making 
the change.


Sec.  830.350  Correction of information submitted to the Global Unique 
Device Identification Database.

    (a) If FDA becomes aware that any information submitted to the 
Global Unique Device Identification Database (GUDID) appears to be 
incorrect or potentially misleading, we may notify the labeler of the 
specific information that appears to be incorrect, and request that the 
labeler provide corrected information or explain why the information is 
correct. The labeler must provide corrected information or provide a 
satisfactory explanation of why the information is correct within 30 
days of receipt of FDA's notification.
    (b) If the labeler does not respond to FDA's notification within 30 
days of receipt, or if FDA determines, at any time, that any 
information in the GUDID is incorrect or could be misleading, we may 
delete or correct the information. Any action taken by FDA under this 
paragraph does not relieve the labeler of its responsibility under 
paragraph (a) of this section to provide corrected information or an 
explanation of why the information previously submitted is correct.


Sec.  830.360  Records to be maintained by the labeler.

    (a) Each labeler shall retain, and submit to FDA upon specific 
request, records showing all unique device identifiers (UDIs) used to 
identify devices that must bear a UDI on their label, and the 
particular version or model associated with each device identifier. 
These records must be retained for 3 years from the date the labeler 
ceases to market the version or model.

[[Page 58828]]

    (b) Compliance with this section does not relieve the labeler of 
the need to comply with recordkeeping requirements of any other FDA 
regulation.

    Dated: September 18, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-23059 Filed 9-20-13; 8:45 am]
BILLING CODE 4160-01-P