Notice2022-21832
Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry and Food and Drug Administration Staff; and Procedures for Handling Post-Approval Studies Imposed by Premarket Approval Application Order; Guidance for Industry and Food and Drug Administration Staff; Availability
Primary source
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Published
October 7, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of the final guidance documents entitled "Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act" and "Procedures for Handling Post-Approval Studies Imposed by PMA [Premarket Approval Application] Order." These guidance documents are intended to facilitate and set expectations for timely initiation and completion of certain studies fulfilling postmarket surveillance requirements and of Post-Approval Studies (PAS), respectively. Additionally, these guidance documents are intended to increase transparency to stakeholders on FDA's approach to the issuance and tracking of postmarket surveillance orders and of PAS requirements. The final guidance "Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act" is intended to update and replace the guidance issued in May 2016; the final guidance "Procedures for Handling Post-Approval Studies Imposed by PMA Order" is intended to update and replace the guidance issued in June 2009.
Full Text
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<title>Federal Register, Volume 87 Issue 194 (Friday, October 7, 2022)</title>
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[Federal Register Volume 87, Number 194 (Friday, October 7, 2022)]
[Notices]
[Pages 61030-61032]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-21832]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-D-0514 and FDA-2005-D-0027]
Postmarket Surveillance Under Section 522 of the Federal Food,
Drug, and Cosmetic Act; Guidance for Industry and Food and Drug
Administration Staff; and Procedures for Handling Post-Approval Studies
Imposed by Premarket Approval Application Order; 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, Agency, or we) is
announcing the availability of the final guidance documents entitled
``Postmarket Surveillance Under Section 522 of the Federal Food, Drug,
and Cosmetic Act'' and ``Procedures for Handling Post-Approval Studies
Imposed by PMA [Premarket Approval Application] Order.'' These guidance
documents are intended to facilitate and set expectations for timely
initiation and completion of certain studies fulfilling postmarket
surveillance requirements and of Post-Approval Studies (PAS),
respectively. Additionally, these guidance documents are intended to
increase transparency to stakeholders on FDA's approach to the issuance
and tracking of postmarket surveillance orders and of PAS requirements.
The final guidance ``Postmarket Surveillance Under Section 522 of the
Federal Food, Drug, and Cosmetic Act'' is intended to update and
replace the guidance issued in May 2016; the final guidance
``Procedures for Handling Post-Approval Studies Imposed by PMA Order''
is intended to update and replace the guidance issued in June 2009.
DATES: The announcement of the guidance is published in the Federal
Register on October 7, 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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-2011-D-0514 for ``Postmarket Surveillance Under Section 522 of the
Federal Food, Drug, and Cosmetic Act'' or Docket No. FDA-2005-D-0027
for ``Procedures for Handling Post-Approval Studies Imposed by PMA
Order.'' Received comments will be placed in the docket and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
<a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between
9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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://
[[Page 61031]]
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 Sec.
10.115(g)(5) (21 CFR 10.115(g)(5))).
Electronic copies of the guidance documents are 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
``Postmarket Surveillance Under Section 522 of the Federal Food, Drug,
and Cosmetic Act'' or ``Procedures for Handling Post-Approval Studies
Imposed by PMA Order'' 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: Megha Reddy, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Silver Spring, MD 20993-0002, 240-402-2980.
SUPPLEMENTARY INFORMATION:
I. Background
The guidance ``Postmarket Surveillance Under Section 522 of the
Federal Food, Drug, and Cosmetic Act'' is intended to assist
manufacturers of devices subject to section 522 orders, by providing:
<bullet> an overview of section 522 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360l),
<bullet> information on how to fulfill section 522 obligations, and
<bullet> recommendations on the format, content, and review of
postmarket surveillance plan and report submissions.
The guidance ``Procedures for Handling Post-Approval Studies
Imposed by PMA Order'' is intended to assist stakeholders with
understanding PAS requirements imposed as a condition of PMA approval
by providing:
<bullet> procedural information,
<bullet> recommendations concerning the format, content, and review
of PAS-related submissions,
<bullet> recommendations to help facilitate FDA's review of a PAS
protocol in a timely manner,
<bullet> recommendations for study timelines including enrollment
milestones and study completion,
<bullet> revised definitions to PAS status categories that we
believe better reflect progress of the PAS, and
<bullet> revised FDA review time goals for PAS-related submissions.
The primary changes for the guidance ``Postmarket Surveillance
Under Section 522 of the Federal Food, Drug, and Cosmetic Act'' from
the 2016 version of this guidance document include: (1) clarification
on when postmarket surveillance is considered commenced, (2)
recommendations for achieving an approved postmarket surveillance plan
in a timely manner, (3) recommendations for postmarket surveillance
completion timelines, (4) updated surveillance status categories to
better reflect progress, (5) revised FDA's review times for postmarket
surveillance related submissions, and (6) updated FDA points of contact
and organizational structure.
A notice of availability of the draft guidance ``Postmarket
Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic
Act'' appeared in the Federal Register of May 27, 2021 (86 FR 28602).
FDA considered comments received and revised this guidance as
appropriate in response to the comments, including (1) by providing
additional clarification on information to be included in postmarket
surveillance plans, enrollment reports, interim reports, and final
reports; (2) additional clarification on how changes to an approved
postmarket surveillance plan should be made by the companies and
reviewed by the FDA; and (3) additional clarification on information to
be posted on FDA's 522 web page.
A notice of availability of the draft guidance ``Procedures for
Handling Post-Approval Studies Imposed by PMA Order'' appeared in the
Federal Register of May 27, 2021 (86 FR 28630). FDA considered comments
received and revised this guidance as appropriate in response to the
comments, including: (1) by providing additional clarification on
information to be included in PAS protocols, enrollment reports,
interim PAS reports, and final PAS reports; (2) additional
clarification on how changes to an approved PAS protocol should be made
by the sponsors and reviewed by the FDA; (3) additional clarification
on using alternative study designs such as Real-World Data; and (4) one
revised definition of PAS status.
These guidance documents are being issued consistent with FDA's
good guidance practices regulation (Sec. 10.115). These guidance
documents represent the current thinking of FDA on ``Postmarket
Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic
Act,'' and ``Procedures for Handling Post-Approval Studies Imposed by
PMA Order,'' respectively. They do not establish any rights for any
person and are 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 guidances 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 <a href="https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products">https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products</a>. These guidance documents are
also available at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>. Persons unable to
download an electronic copy of either ``Postmarket Surveillance Under
Section 522 of the Federal Food, Drug, and Cosmetic Act (document
number 19042)'' or ``Procedures for Handling Post-Approval Studies
Imposed by PMA Order (document number 1043)'' may send an email request
to <a href="/cdn-cgi/l/email-protection#3e7d7a6c7613794b575a5f505d5b7e585a5f1056564d10595148"><span class="__cf_email__" data-cfemail="296a6d7b61046e5c404d48474a4c694f4d480741415a074e465f">[email protected]</span></a> to receive an electronic copy of the
document. Please use the document number and complete title to identify
the guidance you are requesting.
III. Paperwork Reduction Act of 1995
While these guidance documents contain no new collection of
information, they do 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 these guidance documents. 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:
[[Page 61032]]
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21 CFR Part; Guidance; or FDA OMB Control
Form Topic No.
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822............................ Postmarket Surveillance 0910-0449
of Medical Devices.
807, subpart E................. Premarket notification. 0910-0120
814, subparts A through E...... Premarket approval..... 0910-0231
814, subpart H................. Humanitarian Use 0910-0332
Device; Humanitarian
Device Exemption.
860, subpart D................. De Novo classification 0910-0844
process.
``Requests for Feedback and Q-submissions; 0910-0756
Meetings for Medical Device Presubmissions.
Submissions: The Q-Submission
Program''.
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Dated: October 3, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-21832 Filed 10-6-22; 8:45 am]
BILLING CODE 4164-01-P
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