[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
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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