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; Final Guidance for Industry and Food and Drug Administration Staff; and Select Updates for the 506J Guidance: 506J Device List and Additional Notifications; Draft Guidance for Industry and Food and Drug Administration Staff; Availability, 80310-80312 [2023-25458]
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Federal Register / Vol. 88, No. 221 / Friday, November 17, 2023 / Notices
Employees. A maximum of 122
members shall be standing voting
members and 37 shall be nonvoting
members who serve as representatives
of consumer interests and of industry
interests. FDA is publishing separate
documents announcing the Request for
Nominations Notification for Nonvoting
Representatives on certain panels of the
MDAC. Persons nominated for
membership on the panels should have
adequately diversified experience
appropriate to the work of the panel in
such fields as clinical and
administrative medicine, engineering,
biological and physical sciences,
statistics, and other related professions.
The nature of specialized training and
experience necessary to qualify the
nominee as an expert suitable for
appointment may include experience in
medical practice, teaching, and/or
research relevant to the field of activity
of the panel. The current needs for each
panel are listed in table 2. Members will
be invited to serve for terms of up to 4
years.
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III. Nomination Procedures
Any interested person may nominate
one or more qualified individuals for
membership on one or more of the
advisory panels or advisory committees.
Self-nominations are also accepted.
Nominations must include a current,
complete re´sume´ or curriculum vitae for
each nominee, including current
business address, telephone number,
and email address if available and a
signed copy of the Acknowledgement
and Consent form available at the FDA
Advisory Nomination Portal (see
ADDRESSES). Nominations must also
specify the advisory committees or
panel(s) for which the nominee is
recommended. Nominations must also
acknowledge that the nominee is aware
of the nomination unless selfnominated. FDA will ask potential
candidates to provide detailed
information concerning such matters
related to financial holdings,
employment, and research grants and/or
contracts to permit evaluation of
possible sources of conflict of interest.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to advisory committees.
Dated: November 6, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–25367 Filed 11–16–23; 8:45 am]
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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; Final
Guidance for Industry and Food and
Drug Administration Staff; and Select
Updates for the 506J Guidance: 506J
Device List and Additional
Notifications; Draft Guidance for
Industry and Food and Drug
Administration Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of the final
guidance entitled ‘‘Notifying FDA of a
Permanent Discontinuance or
Interruption in Manufacturing of a
Device Under Section 506J of the FD&C
Act’’ and the draft guidance entitled
‘‘Select Updates for the 506J Guidance:
506J Device List and Additional
Notifications.’’ The Federal Food, Drug,
and Cosmetic Act (FD&C Act) requires
manufacturers to notify FDA of a
permanent discontinuance or an
interruption in the manufacture of
certain devices that is likely to lead to
a meaningful disruption in supply of
that device in the United States during
or in advance of a public health
emergency (PHE). This final guidance is
intended to assist manufacturers in
providing timely, informative
notifications about changes in the
production of certain medical device
products that will help prevent or
mitigate shortages of such devices. FDA
is concurrently issuing a draft guidance
to propose select updates to 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 draft guidance proposes a list
of device product codes for which a
manufacturer of such devices is
required to notify FDA in accordance
with the 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 PHE. This draft guidance is not final
nor is it for implementation at this time.
SUMMARY:
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Fmt 4703
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Submit either electronic or
written comments on the draft guidance
by February 15, 2024 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:
DATES:
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’’ or ‘‘Select Updates for the 506J
Guidance: 506J Device List and
Additional Notifications.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
E:\FR\FM\17NON1.SGM
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Federal Register / Vol. 88, No. 221 / Friday, November 17, 2023 / Notices
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-201509-18/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 final guidance
document entitled ‘‘Notifying FDA of a
Permanent Discontinuance or
Interruption in Manufacturing of a
Device Under Section 506J of the FD&C
Act’’ or draft guidance document
entitled ‘‘Select Updates for the 506J
Guidance: 506J Device List and
Additional Notifications’’ to the Office
of Policy, Center for Devices and
VerDate Sep<11>2014
18:57 Nov 16, 2023
Jkt 262001
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, Silver Spring,
MD 20993–0002; or to Office of
Communication, Outreach and
Development, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,
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. 5550, Silver Spring,
MD 20993–0002, 301–796–9081; or
Anne Taylor, 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
On March 27, 2020, the Coronavirus
Aid, Relief, and Economic Security Act
(CARES Act) was signed into law.
Section 3121 of the CARES Act amends
the FD&C Act by adding section 506J to
the statute. Section 506J of the FD&C
Act (21 U.S.C. 356j) provides FDA with
new 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).
Additionally, on December 29, 2022, the
Prepare for and Respond to Existing
Viruses, Emerging New Threats, and
Pandemics Act (‘‘PREVENT Pandemics
Act’’) was signed into law as part of the
Consolidated Appropriations Act, 2023,
Pub. L. 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 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 the FY 2023 Omnibus amended
section 506J to add section 506J(h),
‘‘Additional Notifications’’ and directed
FDA to issue guidance ‘‘to facilitate
voluntary notifications.’’
FDA is issuing this final guidance,
‘‘Notifying FDA of a Permanent
Discontinuance or Interruption in
Manufacturing of a Device Under
Section 506J of the FD&C Act’’ (hereafter
referred to as the ‘‘506J Guidance’’) to
assist stakeholders in the Agency’s
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80311
implementation of section 506J. This
guidance serves as the baseline for
information about notifications under
section 506J during or in advance of any
PHE. FDA provides additional
clarification on who is required to notify
FDA, when such notifications are
required, what information FDA expects
manufacturers to include in such
notifications, and how to submit
notifications. Additionally, FDA
describes how FDA determines that a
device is in shortage and additional
actions FDA may take to help prevent or
mitigate a potential device shortage.
In the draft guidance ‘‘Select Updates
for the 506J Guidance: 506J Device List
and Additional Notifications,’’ FDA
proposes updates to the 506J Guidance.
Specifically, FDA has developed a list of
devices, by FDA product code, for
which a manufacturer of such devices is
required to notify FDA in accordance
with section 506J (hereafter referred to
as the ‘‘506J Device List’’). The 506J
Device List is based on the requirements
under section 506J(a). In section 2514 of
the FY 2023 Omnibus, Congress
directed FDA to issue guidance on the
requirements under section 506J 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 506J 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-andshortages/506j-device-list. Additionally,
consistent with section 506J(h), FDA is
proposing to clarify for stakeholders 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. The
Agency invites comments on both the
506J Device List and the clarification for
stakeholders on voluntary notifications.
A notice of availability of the draft
guidance, ‘‘Notifying FDA of a
Permanent Discontinuance or
Interruption in Manufacturing of a
Device Under Section 506J of the FD&C
Act,’’ appeared in the Federal Register
of January 11, 2022 (87 FR 1417). FDA
considered comments received and
revised the guidance as appropriate in
response to the comments, including
providing additional clarifications such
as when manufactures should notify
FDA of changes in status and when
manufacturers should provide 506J
notification updates, and what
information is required by section 506J
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Federal Register / Vol. 88, No. 221 / Friday, November 17, 2023 / Notices
and what additional information is
helpful to FDA. Additionally, FDA
provided additional transparency
regarding how FDA uses information
from 506J notifications.
These guidances are being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, ‘‘Select Updates for
the 506J Guidance: 506J Device List and
Additional Notifications,’’ when
finalized, will represent 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.’’ These guidances do 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 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-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-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-bloodbiologics/guidance-complianceregulatory-information-biologics.
Persons unable to download an
electronic copy of ‘‘Notifying FDA of a
Permanent Discontinuance or
Interruption in Manufacturing of a
Guidance
Dated: November 14, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
The meeting will be held on
February 2, 2024, from 9 a.m. to 6:30
p.m. Eastern Time.
DATES:
Food and Drug Administration
[Docket No. FDA–2023–N–4916]
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for comments.
ACTION:
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Anesthesiology and
Respiratory Therapy Devices Panel of
the Medical Devices Advisory
Committee (the Committee). The general
function of the Committee is to provide
advice and recommendations to FDA on
regulatory issues. The Committee will
discuss an approach to improve the
quality of premarket studies and
associated methods used to evaluate the
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18:57 Nov 16, 2023
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All meeting participants
will be heard, viewed, captioned, and
recorded for this advisory committee
meeting via an online teleconferencing
and/or video conferencing platform.
Answers to commonly asked questions
about FDA advisory committee meetings
may be accessed at: https://
www.fda.gov/AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm.
FDA is establishing a docket for
public comment on this meeting. The
docket number is FDA–2023–N–4916.
The docket will close on March 4, 2024.
Please note that late, untimely filed
comments will not be considered. The
https://www.regulations.gov electronic
filing system will accept comments
until 11:59 p.m. Eastern Time at the end
of March 4, 2024. Comments received
by mail/hand delivery/courier (for
written/paper submissions) will be
considered timely if they are received
on or before that date.
ADDRESSES:
Anesthesiology and Respiratory
Therapy Devices Panel of the Medical
Devices Advisory Committee; Notice of
Meeting; Establishment of a Public
Docket; Request for Comments—Pulse
Oximeters
VerDate Sep<11>2014
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 No.
Shortages Data Collection ......................................................
performance of pulse oximeters
submitted for premarket review, taking
into consideration a patient’s skin
pigmentation, and patient-reported race
and ethnicity. The meeting will be open
to the public. FDA is establishing a
docket for public comment on this
document.
[FR Doc. 2023–25458 Filed 11–16–23; 8:45 am]
SUMMARY:
III. Paperwork Reduction Act of 1995
Topic
‘‘Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of
the FD&C Act’’.
AGENCY:
Device Under Section 506J of the FD&C
Act’’ or ‘‘Select Updates for the 506J
Guidance: 506J Device List and
Additional Notifications’’ may send an
email request to CDRH-Guidance@
fda.hhs.gov to receive an electronic
copy of the document. Please use the
document number GUI00021003 and
complete title to identify the guidance
you are requesting.
Fmt 4703
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0910–0491
Comments received on or before
January 19, 2024, will be provided to
the Committee. Comments received after
that date will be taken into
consideration by FDA. In the event that
the meeting is canceled, FDA will
continue to evaluate any relevant
applications or information, and
consider any comments submitted to the
docket, as appropriate.
You may submit comments 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.
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]]>Agencies
[Federal Register Volume 88, Number 221 (Friday, November 17, 2023)]
[Notices]
[Pages 80310-80312]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-25458]
-----------------------------------------------------------------------
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; Final
Guidance for Industry and Food and Drug Administration Staff; and
Select Updates for the 506J Guidance: 506J Device List and Additional
Notifications; Draft Guidance for Industry and Food and Drug
Administration Staff; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the final guidance entitled ``Notifying FDA of a
Permanent Discontinuance or Interruption in Manufacturing of a Device
Under Section 506J of the FD&C Act'' and the draft guidance entitled
``Select Updates for the 506J Guidance: 506J Device List and Additional
Notifications.'' The Federal Food, Drug, and Cosmetic Act (FD&C Act)
requires manufacturers to notify FDA of a permanent discontinuance or
an interruption in the manufacture of certain devices that is likely to
lead to a meaningful disruption in supply of that device in the United
States during or in advance of a public health emergency (PHE). This
final guidance is intended to assist manufacturers in providing timely,
informative notifications about changes in the production of certain
medical device products that will help prevent or mitigate shortages of
such devices. FDA is concurrently issuing a draft guidance to propose
select updates to 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 draft guidance proposes a list of
device product codes for which a manufacturer of such devices is
required to notify FDA in accordance with the 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 PHE. This draft guidance is not final nor is it for
implementation at this time.
DATES: Submit either electronic or written comments on the draft
guidance by February 15, 2024 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-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'' or ``Select Updates for the 506J Guidance: 506J Device List
and Additional Notifications.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov
[[Page 80311]]
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 final guidance document entitled
``Notifying FDA of a Permanent Discontinuance or Interruption in
Manufacturing of a Device Under Section 506J of the FD&C Act'' or draft
guidance document entitled ``Select Updates for the 506J Guidance: 506J
Device List and Additional Notifications'' 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; or to Office of Communication, Outreach and
Development, Center for Biologics Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128,
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. 5550, Silver Spring, MD 20993-0002, 301-796-9081;
or Anne Taylor, 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
On March 27, 2020, the Coronavirus Aid, Relief, and Economic
Security Act (CARES Act) was signed into law. Section 3121 of the CARES
Act amends the FD&C Act by adding section 506J to the statute. Section
506J of the FD&C Act (21 U.S.C. 356j) provides FDA with new 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). Additionally,
on December 29, 2022, the Prepare for and Respond to Existing Viruses,
Emerging New Threats, and Pandemics Act (``PREVENT Pandemics Act'') was
signed into law as part of the Consolidated Appropriations Act, 2023,
Pub. L. 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 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
the FY 2023 Omnibus amended section 506J to add section 506J(h),
``Additional Notifications'' and directed FDA to issue guidance ``to
facilitate voluntary notifications.''
FDA is issuing this final guidance, ``Notifying FDA of a Permanent
Discontinuance or Interruption in Manufacturing of a Device Under
Section 506J of the FD&C Act'' (hereafter referred to as the ``506J
Guidance'') to assist stakeholders in the Agency's implementation of
section 506J. This guidance serves as the baseline for information
about notifications under section 506J during or in advance of any PHE.
FDA provides additional clarification on who is required to notify FDA,
when such notifications are required, what information FDA expects
manufacturers to include in such notifications, and how to submit
notifications. Additionally, FDA describes how FDA determines that a
device is in shortage and additional actions FDA may take to help
prevent or mitigate a potential device shortage.
In the draft guidance ``Select Updates for the 506J Guidance: 506J
Device List and Additional Notifications,'' FDA proposes updates to the
506J Guidance. Specifically, FDA has developed a list of devices, by
FDA product code, for which a manufacturer of such devices is required
to notify FDA in accordance with section 506J (hereafter referred to as
the ``506J Device List''). The 506J Device List is based on the
requirements under section 506J(a). In section 2514 of the FY 2023
Omnibus, Congress directed FDA to issue guidance on the requirements
under section 506J 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 506J
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. Additionally, consistent with section 506J(h), FDA is proposing
to clarify for stakeholders 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.
The Agency invites comments on both the 506J Device List and the
clarification for stakeholders on voluntary notifications.
A notice of availability of the draft guidance, ``Notifying FDA of
a Permanent Discontinuance or Interruption in Manufacturing of a Device
Under Section 506J of the FD&C Act,'' appeared in the Federal Register
of January 11, 2022 (87 FR 1417). FDA considered comments received and
revised the guidance as appropriate in response to the comments,
including providing additional clarifications such as when manufactures
should notify FDA of changes in status and when manufacturers should
provide 506J notification updates, and what information is required by
section 506J
[[Page 80312]]
and what additional information is helpful to FDA. Additionally, FDA
provided additional transparency regarding how FDA uses information
from 506J notifications.
These guidances are being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance,
``Select Updates for the 506J Guidance: 506J Device List and Additional
Notifications,'' when finalized, will represent 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.'' These
guidances do 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 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
``Notifying FDA of a Permanent Discontinuance or Interruption in
Manufacturing of a Device Under Section 506J of the FD&C Act'' or
``Select Updates for the 506J Guidance: 506J Device List and Additional
Notifications'' 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:
------------------------------------------------------------------------
Guidance Topic OMB control No.
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``Notifying FDA of a Permanent Shortages Data 0910-0491
Discontinuance or Collection.
Interruption in Manufacturing
of a Device Under Section
506J of the FD&C Act''.
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Dated: November 14, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-25458 Filed 11-16-23; 8:45 am]
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