[Federal Register Volume 87, Number 17 (Wednesday, January 26, 2022)]
[Notices]
[Pages 4036-4037]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-01374]



[[Page 4036]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-3846]


Patient Engagement in the Design and Conduct of Medical Device 
Clinical Studies; Guidance for Industry, Food and Drug Administration 
Staff, and Other Stakeholders; 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 ``Patient Engagement in 
the Design and Conduct of Medical Device Clinical Studies.'' The 
Patient Engagement Advisory Committee (PEAC) recommended that FDA and 
industry develop a framework to clarify how patient advisors can engage 
in the clinical investigation process. This guidance focuses on the 
applications, perceived barriers, and common challenges of patient 
engagement in the design and conduct of medical device clinical 
studies.

DATES: The announcement of the guidance is published in the Federal 
Register on January 26, 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-2019-D-3846 for ``Patient Engagement in the Design and Conduct of 
Medical Device Clinical Studies.'' 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 guidance document entitled 
``Patient Engagement in the Design and Conduct of Medical Device 
Clinical Studies'' 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 or the 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: Michelle Tarver, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 5608, Silver Spring, MD 20993-0002, 301-
796-6884 or Stephen Ripley, 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 October 11 and 12, 2017, the PEAC met to discuss and make 
recommendations regarding patient engagement into medical device 
clinical studies. The PEAC stated that some framework should be 
developed by FDA and industry to clarify how patient advisors can 
engage in the clinical study process. Based on this recommendation, FDA 
is pursuing various efforts of

[[Page 4037]]

encouraging voluntary patient engagement in clinical studies, including 
guidance. FDA believes medical device clinical studies designed with 
patient input may help to address common challenges faced in medical 
device clinical studies.
    While FDA acknowledges that patient engagement may be beneficial 
across the total product lifecycle, this guidance focuses on the 
applications of patient engagement in the design and conduct of medical 
device clinical studies. The guidance will: (1) Help sponsors 
understand how they can voluntarily use patient engagement to elicit 
experience, perspectives, and other relevant information from patient 
advisors (see definition in section IV) to improve the design and 
conduct of medical device clinical studies; (2) highlight the benefits 
of engaging with patient advisors early in the medical device 
development process; (3) illustrate which patient engagement activities 
are generally not considered by FDA to constitute research or an 
activity subject to FDA's regulations, including regulations regarding 
institutional review boards (IRBs); and (4) address common questions 
and misconceptions about collecting and submitting to FDA patient 
engagement information regarding the design and conduct of a medical 
device clinical study.
    A notice of availability of the draft guidance appeared in the 
Federal Register of September 24, 2019 (84 FR 50047). FDA considered 
comments received and revised the guidance as appropriate in response 
to the comments, including clarifying terminology, adding additional 
background on patient engagement efforts at FDA, and clarifying how 
sponsors can obtain specific feedback from FDA on patient engagement 
plans and patient-centered study designs.
    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 patient engagement in the design and conduct 
of medical device clinical studies. 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 and at https://www.fda.gov/regulatory-information/search-fda-guidance-documents or https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances. Persons unable to download 
an electronic copy of ``Patient Engagement in the Design and Conduct of 
Medical Device Clinical Studies'' may send an email request to [email protected] to receive an electronic copy of the document. 
Please use the document number 18040 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, guidance, and forms 
have been approved by OMB as listed in the following table:

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                                                            OMB control
      21 CFR part or guidance               Topic               No.
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807, subpart E....................  Premarket                  0910-0120
                                     Notification.
814, subparts A through E.........  Premarket Approval..       0910-0231
814, subpart H....................  Humanitarian Device        0910-0332
                                     Exemption.
812...............................  Investigational            0910-0078
                                     Device Exemption.
``De Novo Classification Process    De Novo                    0910-0844
 (Evaluation of Automatic Class      Classification
 III Designation)''.                 Process.
``FDA and Industry Procedures for   513(g) Request for         0910-0705
 Section 513(g) Requests for         Information.
 Information under the Federal
 Food, Drug, and Cosmetic Act''.
``Requests for Feedback on Medical  Q-submissions.......       0910-0756
 Device Submissions: The Pre-
 Submission Program and Meetings
 with Food and Drug Administration
 Staff''.
56................................  Institutional Review       0910-0130
                                     Boards.
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    Dated: January 19, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-01374 Filed 1-25-22; 8:45 am]
BILLING CODE 4164-01-P


