Document ID: FDA-2011-D-0514-0026
Agency: fda
Document Type: Notice
Title: 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 - Final Guidance
Posted Date: 2022-10-07T04:00Z

[Federal Register Volume 87, Number 194 (Friday, October 7, 2022)]
[Notices]
[Pages 61030-61032]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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:
     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-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 
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://

[[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 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 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:
     an overview of section 522 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360l),
     information on how to fulfill section 522 obligations, and
     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:
     procedural information,
     recommendations concerning the format, content, and review 
of PAS-related submissions,
     recommendations to help facilitate FDA's review of a PAS 
protocol in a timely manner,
     recommendations for study timelines including enrollment 
milestones and study completion,
     revised definitions to PAS status categories that we 
believe better reflect progress of the PAS, and
     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 https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. These guidance documents are 
also available at https://www.regulations.gov or https://www.fda.gov/regulatory-information/search-fda-guidance-documents. 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 [email protected] 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