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[Federal Register Volume 90, Number 4 (Tuesday, January 7, 2025)]
[Notices]
[Pages 1152-1154]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-31547]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-0053]

Notifying the Food and Drug Administration of a Permanent 
Discontinuance or Interruption in Manufacturing of a Device Under 
Section 506J of the Federal Food, Drug, and Cosmetic Act; 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 or Agency) is announcing 
the availability of a final guidance entitled ``Notifying FDA of a 
Permanent Discontinuance or Interruption in Manufacturing of a Device 
Under Section 506J of the FD&C Act.'' This guidance updates the 
previous version of the guidance, of the same title, issued on November 
17, 2023, and finalizes the concurrently issued draft guidance entitled 
``Select Updates for the 506J Guidance: 506J Device List and Additional 
Notifications.'' This guidance finalizes a list of device product codes 
for which a manufacturer of such devices is required to notify FDA in 
accordance with the Federal Food, Drug, and Cosmetic Act (FD&C Act) 
(hereafter referred to as the ``506J Device List'') and clarifies that 
manufacturers may submit voluntary notifications regarding supply chain 
issues at any time, unrelated to the declaration or potential 
declaration of a public health emergency (PHE).

DATES: The announcement of the guidance is published in the Federal 
Register on January 7, 2025.

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-2022-D-0053 for ``Notifying FDA of a Permanent Discontinuance or 
Interruption in Manufacturing of a Device Under Section 506J of the 
FD&C Act.'' 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)).

[[Page 1153]]

    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 
``Notifying FDA of a Permanent Discontinuance or Interruption in 
Manufacturing of a Device Under Section 506J of the FD&C Act'' 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: Tammy Beckham, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5500, Silver Spring, MD 20993-0002, 301-796-9081 or 
James Myers, 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

    Section 506J of the FD&C Act (21 U.S.C. 356j) provides FDA with 
authorities intended to help prevent or mitigate device shortages 
``during, or in advance of, a public health emergency'' declared under 
section 319 of the Public Health Service Act (PHS Act) (42 U.S.C. 
247d). On December 29, 2022, the Prepare for and Respond to Existing 
Viruses, Emerging New Threats, and Pandemics Act was signed into law as 
part of the Consolidated Appropriations Act, 2023, Public Law 117-328 
(hereafter referred to as the FY 2023 Omnibus). Section 2514(c) of the 
FY 2023 Omnibus directed FDA to issue or revise guidance regarding 
requirements under section 506J of the FD&C Act and include a list of 
each device product code for which a manufacturer of such device is 
required to notify FDA in accordance with section 506J. Section 2514 of 
the FY 2023 Omnibus amended section 506J of the FD&C Act to add section 
506J(h), ``Additional Notifications'' and directed FDA to issue 
guidance ``to facilitate voluntary notifications.''
    This final guidance includes the 506J Device List. The 506J Device 
List is based on the requirements under section 506J(a) of the FD&C 
Act. In section 2514 of the FY 2023 Omnibus, Congress directed FDA to 
issue guidance on the requirements under section 506J of the FD&C Act 
and to include ``a list of each device product code for which a 
manufacturer of such device is required to notify the Secretary in 
accordance with section 506J.'' Thus, manufacturers of a device on the 
506J Device List must notify FDA in accordance with section 506J of the 
FD&C Act for each such device. For more information, manufacturers 
should see the 506J Device List web page, available at https://www.fda.gov/medical-devices/medical-device-supply-chain-and-shortages/506j-device-list. FDA expects that the list will evolve over time and 
FDA intends to periodically reevaluate the list.
    Additionally, consistent with section 506J(h) of the FD&C Act, FDA 
has clarified that manufacturers may submit, and FDA may receive, 
voluntary notifications regarding supply chain issues at any time, 
unrelated to the declaration or potential declaration of a PHE.
    This guidance updates the final guidance ``Notifying FDA of a 
Permanent Discontinuance or Interruption in Manufacturing of a Device 
Under Section 506J of the FD&C Act.'' This guidance also finalizes the 
concurrently issued draft guidance entitled ``Select Updates for the 
506J Guidance: 506J Device List and Additional Notifications.'' A 
notice of availability for these guidances appeared in the Federal 
Register of November 17, 2023 (88 FR 80310). Additionally, FDA received 
recommendations from the General Hospital and Personal Use Devices 
Panel of the Medical Devices Advisory Committee on February 6, 2024. 
FDA considered comments received and revised the draft guidance as 
appropriate in response to the comments, including updating the 506J 
Device List and providing additional clarity regarding the development 
of the 506J Device List. The guidance also includes additional 
information regarding potential updates to the 506J Device List and how 
to contact FDA regarding devices on the 506J Device List.
    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 ``Notifying FDA of a Permanent 
Discontinuance or Interruption in Manufacturing of a Device Under 
Section 506J of the FD&C Act.'' 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 
``Notifying FDA of a Permanent Discontinuance or Interruption in 
Manufacturing of a Device Under Section 506J of the FD&C Act'' may send 
an email request to [email protected] to receive an electronic 
copy of the document. Please use the document number GUI00021003 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. The 
previously approved collections of information are subject to review by 
the Office of Management and Budget (OMB) under the Paperwork Reduction 
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information 
in the following table have been approved by OMB:

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                                                            OMB control
             Guidance                       Topic               No.
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``Notifying FDA of a Permanent      Shortages Data             0910-0491
 Discontinuance or Interruption in   Collection.
 Manufacturing of a Device Under
 Section 506J of the FD&C Act''.
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[[Page 1154]]

    Dated: December 26, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2024-31547 Filed 1-6-25; 8:45 am]
BILLING CODE 4164-01-P
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