[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17, 2023, and finalizes the concurrently issued draft guidance entitled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