[Federal Register Volume 86, Number 101 (Thursday, May 27, 2021)]
[Notices]
[Pages 28630-28631]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-11216]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2005-D-0027]


Procedures for Handling Post-Approval Studies Imposed by 
Premarket Approval Application Order; Draft Guidance for Industry and 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the availability of the draft guidance entitled ``Procedures for 
Handling Post-Approval Studies Imposed by Premarket Approval 
Application Order.'' The existing post-approval studies final guidance, 
entitled ``Procedures for Handling Post-Approval Studies Imposed by PMA 
Order,'' was issued in June 2009. This draft guidance is intended to 
update the 2009 guidance to assist stakeholders with understanding 
post-approval study requirements imposed as a condition of approval of 
a premarket approval application (PMA). This draft guidance is not 
final nor is it in effect at this time.

DATES: Submit either electronic or written comments on the draft 
guidance by July 26, 2021 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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-2005-D-0027 for ``Procedures for Handling Post-Approval Studies 
Imposed by Premarket Approval Application 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://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 draft guidance document entitled 
``Procedures for Handling Post-Approval Studies Imposed by Premarket 
Approval Application Order'' to the Office of Policy, Guidance and 
Policy Development, 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: Nilsa Loyo-Berrios, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. G114, Silver Spring, MD 20993-0002, 301-
796-6065.

SUPPLEMENTARY INFORMATION:

I. Background

    To provide reasonable assurance, or the continued assurance, of 
safety and effectiveness of an approved device, FDA may require a post-
approval study (PAS) as a condition of approval under 21 CFR 
814.82(a)(2) and (a)(9). A PAS is usually a clinical or non-clinical 
study, as specified in the PMA approval order, and is typically 
intended to gather specific data to address questions about the 
postmarket performance of or experience with an approved medical 
device. As described in ``Balancing Premarket and Postmarket Data 
Collection for Devices Subject to Premarket Approval,'' FDA may

[[Page 28631]]

consider it acceptable to collect certain data in the postmarket 
setting, rather than premarket under certain circumstances when FDA has 
uncertainty regarding certain benefits or risks of the device, but the 
degree of uncertainty is acceptable in the context of the overall 
benefit-risk profile of the device at the time of premarket approval. 
The purpose of this draft guidance document is to assist stakeholders 
with understanding PAS requirements imposed as a condition of a PMA by 
providing:
     Procedural information;
     recommendations concerning the format, content, and review 
of PAS-related submissions; and
     updates to the final guidance entitled ``Procedures for 
Handling Post-Approval Studies Imposed by PMA Order'' dated June 2009, 
including:
    [cir] Recommendations to help facilitate FDA's review of a PAS 
protocol in a timely manner;
    [cir] recommendations for study timelines including enrollment 
milestones and study completion;
    [cir] revised definitions to PAS status categories that we believe 
better reflect progress of the PAS; and
    [cir] revised FDA review time goals for PAS-related submissions.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on ``Procedures 
for Handling Post-Approval Studies Imposed by Premarket Approval 
Application Order.'' 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 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 is also 
available at https://www.regulations.gov and at https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Persons unable to 
download an electronic copy of ``Procedures for Handling Post-Approval 
Studies Imposed by Premarket Approval Application Order'' may send an 
email request to CDRH-Guidance@fda.hhs.gov to receive an electronic 
copy of the document. Please use the document number 19043 and complete 
title to identify the guidance you are requesting.

III. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does 
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 this guidance. The previously approved collections of 
information are subject to review by OMB under the PRA. The collections 
of information in the following FDA regulations have been approved by 
OMB as listed in the following table:

------------------------------------------------------------------------
                                                            OMB control
          21 CFR part                     Topic                 No.
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814, subparts A through E......  Premarket approval.....       0910-0231
814, subpart H.................  Humanitarian use              0910-0332
                                  devices; Humanitarian
                                  device exemption.
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    Dated: May 21, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-11216 Filed 5-26-21; 8:45 am]
BILLING CODE 4164-01-P


