[Federal Register Volume 84, Number 185 (Tuesday, September 24, 2019)]
[Notices]
[Pages 50047-50048]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-20593]
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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Clinical Investigations; Draft Guidance for Industry, Food and Drug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the availability of the draft guidance entitled ``Patient Engagement in
the Design and Conduct of Medical Device Clinical Investigations.'' The
Patient Engagement Advisory Committee (PEAC) recommended that FDA and
industry develop some type of framework to clarify how patient advisors
can engage in the clinical investigation process. This draft guidance
focuses on the applications, perceived barriers, and common challenges
of patient engagement in the design and conduct of medical device
clinical investigations. This draft guidance is not final nor is it in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DATES: Submit either electronic or written comments on the draft
guidance by November 25, 2019 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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-2019-D-3846 for ``Patient Engagement in the Design and Conduct of
Medical Device Clinical Investigations.'' 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.
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
[[Page 50048]]
``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.gpo.gov/fdsys/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.
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
``Patient Engagement in the Design and Conduct of Clinical
Investigations'' 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 to 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: Mimi Nguyen, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5437, Silver Spring, MD 20993-0002, 301-796-4125;
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 investigations. The PEAC stated that some framework should be
developed by FDA and industry to clarify how patient advisors can
engage in the clinical investigation process. Based on this
recommendation, FDA is pursuing various efforts of patient engagement
in clinical trials, including guidance. FDA believes medical device
clinical investigations designed with patient input may help to address
common challenges faced in medical device clinical investigations.
While FDA acknowledges that patient engagement may be beneficial
across the total product lifecycle, this draft guidance focuses on the
applications of patient engagement in the design and conduct of medical
device clinical investigations.
II. Significance of Guidance
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 ``Patient
Engagement in the Design and Conduct of Clinical Investigations.'' 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. This guidance
is not subject to Executive Order 12866.
III. 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 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 Clinical
Investigations'' may send an email request to [email protected]
to receive an electronic copy of the document. Please use the document
number 18040 to identify the guidance you are requesting.
IV. Paperwork Reduction Act of 1995
This draft guidance refers to previously approved collections of
information. These collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3520). 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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21 CFR part; guidance; or FDA
form Topic OMB control 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.
``Requests for Feedback on Q-submissions...... 0910-0756
Medical Device Submissions: The
Pre-Submission Program and
Meetings with Food and Drug
Administration Staff''.
50, 56.......................... Protection of Human 0910-0755
Subjects: Informed
Consent;
Institutional
Review Boards.
56.............................. Institutional 0910-0130
Review Boards.
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Dated: September 18, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-20593 Filed 9-23-19; 8:45 am]
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