[Federal Register Volume 86, Number 196 (Thursday, October 14, 2021)]
[Notices]
[Pages 57154-57156]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-22308]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-6841]


Select Updates for Unique Device Identification: Policy Regarding 
Global Unique Device Identification Database Requirements for Certain 
Devices; Draft Guidance for Industry and Food and Drug Administration 
Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
announcing the availability of the draft guidance entitled ``Select 
Updates for Unique Device Identification: Policy Regarding Global 
Unique Device Identification Database Requirements for Certain Devices; 
Draft Guidance for Industry and Food and Drug Administration Staff.'' 
This draft guidance explains that there are certain class I devices for 
which FDA does not intend to enforce Global Unique Device 
Identification Database (GUDID) submission requirements and describes 
how a labeler of a class I device can determine if its device is one of 
these devices in the revised section III of this draft guidance. When 
this draft guidance is finalized, the updates in section III of this 
draft guidance would supersede the recommendations in section III of 
the guidance ``Unique Device Identification: Policy Regarding 
Compliance Dates for Class I and Unclassified Devices and Certain 
Devices Requiring Direct Marking''

[[Page 57155]]

(``2020 UDI Compliance Policy Guidance,'' available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/unique-device-identification-policy-regarding-compliance-dates-class-i-and-unclassified-devices-and). This draft guidance is not final nor is 
it in effect at this time.

DATES: Submit either electronic or written comments on the draft 
guidance by December 13, 2021 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as 
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2017-D-6841 for ``Select Updates for Unique Device Identification: 
Policy Regarding Global Unique Device Identification Database 
Requirements for Certain Devices; Draft Guidance for Industry and Food 
and Drug Administration Staff.'' Received comments will be placed in 
the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through 
Friday, 240-402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    An electronic copy of the guidance document is available for 
download from the internet. See the SUPPLEMENTARY INFORMATION section 
for information on electronic access to the guidance. Submit written 
requests for a single hard copy of the draft guidance document entitled 
``Select Updates for Unique Device Identification: Policy Regarding 
Global Unique Device Identification Database Requirements for Certain 
Devices; Draft Guidance for Industry and Food and Drug Administration 
Staff'' to the Office of Policy, Guidance and Policy Development, 
Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver 
Spring, MD 20993-0002; or the Center for Biologics Evaluation and 
Research, Office of Communication, Outreach and Development, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993. Send one 
self-addressed adhesive label to assist that office in processing your 
request.

FOR FURTHER INFORMATION CONTACT: Steven Luxenberg, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 32, Rm. 3216, Silver Spring, MD 20993-0002, 301-
796-5995; or Stephen Ripley, Center for Biologics Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
71, Rm. 7301, Silver Spring, MD 20993, 240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance entitled ``Select 
Updates for Unique Device Identification: Policy Regarding Global 
Unique Device Identification Database Requirements for Certain Devices; 
Draft Guidance for Industry and Food and Drug Administration Staff.'' 
On September 24, 2013 (78 FR 58786), FDA published a final rule 
establishing a unique device identification system designed to 
adequately identify devices through distribution and use (the UDI 
Rule). Phased implementation of the regulatory requirements set forth 
in that final rule is based on a series of established compliance dates 
based primarily on device classification.
    The UDI Rule requires a device to bear a UDI on its label and 
packages, unless an exception or alternative applies (see 21 CFR 
801.20), and special labeling requirements apply to stand-alone 
software regulated as a device (21 CFR 801.50). The UDI Rule also 
requires that data pertaining to the key characteristics of each device 
required to bear a UDI be submitted to FDA's GUDID (Sec.  830.300 (21 
CFR 830.300)). In addition, the UDI Rule added 21 CFR 801.18, which 
requires certain dates on device labels to be in a standard format.

[[Page 57156]]

For devices that: (1) Must bear UDIs on their labels and (2) are 
intended to be used more than once and reprocessed between uses, 21 CFR 
801.45 requires the devices to be directly marked with a UDI. 
Compliance dates for these labeling, GUDID data submission, standard 
date format, and direct marking requirements can be found in the 
preamble to the UDI Rule (78 FR 58786 at 58815 to 58816). For more 
information about UDI compliance dates, please see the UDI web page, 
available at: https://www.fda.gov/medical-devices/unique-device-identification-system-udi-system/compliance-dates-udi-requirements.
    For labelers of class I devices, FDA has developed this draft 
guidance to revise section III. ``Policy On Standard Date Formatting, 
UDI Labeling, and GUDID Submission Requirements for Class I and 
Unclassified Devices'' of the guidance entitled ``Unique Device 
Identification: Policy Regarding Compliance Dates for Class I and 
Unclassified Devices and Certain Devices Requiring Direct Marking'' 
(``2020 UDI Compliance Policy Guidance'', available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/unique-device-identification-policy-regarding-compliance-dates-class-i-and-unclassified-devices-and), which was issued on July 1, 2020. When 
this draft guidance is finalized, the updates in section III of this 
draft guidance would supersede the recommendations in section III of 
the 2020 UDI Compliance Policy Guidance. FDA considered comments 
received on the guidance that appeared in the Federal Register on July 
1, 2020 (85 FR 39477) as the Agency revised the guidance.
    This draft guidance explains that there are certain class I devices 
for which FDA does not intend to enforce GUDID submission requirements 
under Sec.  830.300 and describes how a labeler of a class I device can 
determine if its device is considered a consumer health product. FDA 
has determined that the entry of UDI data into GUDID for these devices 
is burdensome to stakeholders. After undertaking a public health impact 
analysis, the Center for Devices and Radiological Health has a better 
understanding of the devices and device characteristics for which GUDID 
information is particularly useful in evaluating and improving device 
safety throughout a product life cycle, as well as the ones for which 
GUDID information may be less important in this regard. The policy 
proposed in this draft guidance is based on this analysis. We are 
proposing this change in policy through guidance to allow FDA and 
stakeholders an opportunity to fully assess its impact on public 
health. FDA will take the assessment into account in determining 
whether regulations on this subject should be amended in the future.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on ``Select 
Updates for Unique Device Identification: Policy Regarding Global 
Unique Device Identification Database Requirements for Certain Devices; 
Draft Guidance for Industry and Food and Drug Administration Staff''. 
It does not establish any rights for any person and is not binding on 
FDA or the public. You can use an alternative approach if it satisfies 
the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no new collection of information, it 
does refer to previously approved FDA collections of information. 
Therefore, clearance by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required for this guidance. The previously approved collections of 
information are subject to review by OMB under the PRA. The collections 
of information in the following FDA regulations have been approved by 
OMB as listed in the following table:

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                                                            OMB control
            21 CFR part                     Topic               No.
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801 subpart B and 830.............  Unique Device              0910-0720
                                     Identification.
800, 801, and 809.................  Medical Device             0910-0485
                                     Labeling
                                     Regulations.
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III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do 
so by downloading an electronic copy from the internet. A search 
capability for all Center for Devices and Radiological Health guidance 
documents is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also 
available at https://www.regulations.gov, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics. Persons unable to download an electronic copy of 
``Select Updates for Unique Device Identification: Policy Regarding 
Global Unique Device Identification Database Requirements for Certain 
Devices; Draft Guidance for Industry and Food and Drug Administration 
Staff'' may send an email request to [email protected] to 
receive an electronic copy of the document. Please use the document 
number 17029 and complete title to identify the guidance you are 
requesting.

    Dated: October 7, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-22308 Filed 10-13-21; 8:45 am]
BILLING CODE 4164-01-P


