[Federal Register Volume 87, Number 141 (Monday, July 25, 2022)]
[Rules and Regulations]
[Pages 43987-43989]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-15828]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 801

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


Unique Device Identification: Policy Regarding Compliance Dates 
for Class I and Unclassified Devices, Direct Marking, and Global Unique 
Device Identification Database Requirements for Certain Devices; 
Guidance for Industry and Food and Drug Administration Staff; 
Availability

AGENCY: Food and Drug Administration, Department of Health and Human 
Services (HHS).

ACTION: Availability of guidance.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a final guidance entitled ``Unique Device 
Identification: Policy Regarding Compliance Dates for Class I and 
Unclassified Devices, Direct Marking, and Global Unique Device 
Identification Database Requirements for Certain Devices.'' This 
guidance updates the previous version of the guidance, ``Unique Device 
Identification: Policy Regarding Compliance Dates for Class I and 
Unclassified Devices and Certain Devices Requiring Direct Marking,'' 
issued July 1, 2020. This final guidance explains FDA's compliance 
policy regarding Global Unique Device Identification Database (GUDID) 
submission requirements for certain class I devices considered consumer 
health products and describes how a labeler of a class I devices can 
determine if its device is one of these devices. Additionally, the 
guidance explains that FDA intends to extend our existing compliance 
policy regarding GUDID submission requirements for class I and 
unclassified devices, other than implantable, life-supporting, or life-
sustaining (I/LS/LS) devices, for an additional 75 calendar days.

DATES: The announcement of the guidance is published in the Federal 
Register on July 25, 2022.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances 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 ``Unique Device Identification: Policy Regarding 
Compliance Dates for Class I and Unclassified Devices, Direct Marking, 
and Global Unique Device Identification Database Requirements for 
Certain Devices.'' 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

[[Page 43988]]

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 guidance document entitled 
``Unique Device Identification: Policy Regarding Compliance Dates for 
Class I and Unclassified Devices, Direct Marking, and Global Unique 
Device Identification Database Requirements for Certain Devices'' to 
the Office of Policy, Center for Devices and Radiological Health, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, 
Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to 
assist that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Indira Konduri, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1104, Silver Spring, MD 20993-0002, 301-796-6658 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 final guidance entitled 
``Unique Device Identification: Policy Regarding Compliance Dates for 
Class I and Unclassified Devices, Direct Marking, and Global Unique 
Device Identification Database Requirements for Certain Devices.'' 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 unique device identifier 
(UDI) on its label and packages unless an exception or alternative 
applies (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. 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 submission, standard 
date format, and direct marking requirements can be found in the 
preamble to the UDI Rule (78 FR 58815-58816). 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.
    This final guidance supersedes the guidance: ``Unique Device 
Identification: Policy Regarding Compliance Dates for Class I and 
Unclassified Devices and Certain Devices Requiring Direct Marking, 
Immediately In Effect Guidance for Industry and Food and Drug 
Administration Staff'' (``2020 UDI Compliance Policy Guidance''), 
issued July 1, 2020 (85 FR 39477). This guidance explains FDA's 
compliance policy regarding GUDID submission requirements under Sec.  
830.300 for certain class I devices considered consumer health products 
and describes how a labeler of a class I device can determine whether 
its device is within the scope of that policy. With respect to class I 
devices that are consumer health products, as described in the 
guidance, FDA believes that the entry of UDI data into GUDID, 
especially given the frequent changes to the Universal Product Codes 
(UPCs) serving as the UDIs for these devices, is burdensome to 
stakeholders. Further, FDA considered the public health benefit of 
GUDID submission for consumer health products and the risks to public 
health if GUDID submission is not provided for these devices. After 
reviewing available postmarket information, such as medical device 
reports and recall data for class I devices, FDA 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 lifecycle, as well as those for which GUDID 
information may be less important in this regard. Based on this 
analysis, at this time, FDA does not intend to enforce the GUDID 
submission requirements under Sec.  830.300 for consumer health 
products. We are implementing this change in policy through guidance to 
allow FDA and stakeholders an opportunity to fully assess its impact on 
public health. FDA may consider amending its regulations on this 
subject in the future.
    In addition, the final guidance explains that we intend to extend 
our existing compliance policy regarding GUDID submission requirements 
for class I and unclassified devices, other than I/LS/LS devices, 
regardless of whether they are consumer health products, for an 
additional 75 calendar days. In the 2020 UDI Compliance Policy 
Guidance, FDA stated that we did not intend to enforce the GUDID 
submission requirements under Sec.  830.300 for class I and 
unclassified devices, other than I/LS/LS devices, before September 24, 
2022. At this time, in light of the considerations described in the 
guidance, FDA does not intend to enforce the GUDID submission 
requirements under Sec.  830.300 for class I and unclassified devices, 
other than I/LS/LS devices, before December 8, 2022.
    This guidance finalizes the draft guidance entitled ``Select 
Updates for Unique Device Identification: Policy Regarding Global 
Unique Device Identification Requirements for Certain Devices.'' A 
notice of availability of the draft guidance appeared in the Federal 
Register of October 14, 2021 (86 FR 57154). FDA considered comments 
received and revised the guidance as

[[Page 43989]]

appropriate in response to the comments, including further clarifying 
which devices are considered consumer health products.
    The portion of this guidance describing the 75-day extension of 
FDA's existing compliance policy regarding GUDID submission 
requirements for class I and unclassified devices, other than I/LS/LS 
devices, is being implemented without prior public comment because the 
Agency has determined that prior public participation is not feasible 
or appropriate (see section 701(h)(1)(C) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 371(h)(1)(C)) and 21 CFR 10.115(g)(2)). FDA has 
determined that this is a less burdensome policy that is consistent 
with public health. Although this policy is being implemented 
immediately without prior comment, FDA will consider all comments 
received and revise the guidance document as appropriate.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on ``Unique Device Identification: Policy 
Regarding Compliance Dates for Class I and Unclassified Devices, Direct 
Marking, and Global Unique Device Identification Database Requirements 
for Certain Devices.'' 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. Electronic Access

    Persons interested in obtaining a copy of the 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 
``Unique Device Identification: Policy Regarding Compliance Dates for 
Class I and Unclassified Devices, Direct Marking, and Global Unique 
Device Identification Database Requirements for Certain Devices'' 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.

III. 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, guidance, and forms 
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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    Dated: July 19, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-15828 Filed 7-22-22; 8:45 am]
BILLING CODE 4164-01-P