[Federal Register Volume 91, Number 60 (Monday, March 30, 2026)]
[Notices]
[Pages 15622-15624]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2026-06063]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-D-1580]
Incorporating Voluntary Patient Preference Information Over the
Total Product Life Cycle; Guidance for Industry, Food and Drug
Administration Staff, and Other Interested Parties; 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 ``Incorporating Voluntary
Patient Preference
[[Page 15623]]
Information over the Total Product Life Cycle.'' Patients provide
valuable input to FDA in a variety of forms. This guidance describes
the principles and concepts that FDA recommends sponsors and other
interested parties consider when collecting and submitting patient
preference information (PPI), discusses FDA's inclusion of PPI in its
decision summaries, and provides recommendations for the inclusion of
such information in device labeling for certain devices. PPI can be
used in FDA decision making across the total product life cycle,
including during review of investigational device exemption (IDE)
applications, requests for a Breakthrough Device designation, premarket
approval (PMA) applications, humanitarian device exemption (HDE)
applications, De Novo classification requests, premarket notifications
(510(k)s), or for FDA decisions involving administrative, enforcement,
or other actions.
DATES: The announcement of the guidance is published in the Federal
Register on March 30, 2026.
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-2015-D-1580 for ``Incorporating Voluntary Patient Preference
Information over the Total Product Life Cycle.'' 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
``Incorporating Voluntary Patient Preference Information over the Total
Product Life Cycle'' to the Office of Policy, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5441, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
request.
FOR FURTHER INFORMATION CONTACT: Erica Takai, Center for Devices and
Radiological Health, Food and Drug Administration, 301-796-6353; or
Phillip Kurs, Center for Biologics Evaluation and Research, Food and
Drug Administration, 240-402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA believes that patients can and should bring their own
experiences to bear in helping the Agency to evaluate the benefit-risk
profiles of certain devices. This kind of input can be important to
consider during FDA's decision making for these devices across the
total product life cycle. This guidance updates the recommendations in
the 2016 guidance entitled ``Patient Preference Information--Voluntary
Submission, Review in Premarket Approval Applications, Humanitarian
Device Exemption Applications, and De Novo Requests, and Inclusion in
Decision Summaries and Device Labeling'' (``2016 PPI Guidance''). Since
the issuance of the 2016 PPI Guidance, there have been many
developments in the use of PPI for devices, including an increase in
industry-sponsored PPI studies provided to FDA for consideration as
part of a benefit-risk assessment, and numerous collaborations between
FDA scientists and a variety of interested parties to conduct PPI
studies to inform clinical trial design and FDA decision making across
a wide range of diseases, conditions, and device areas. FDA has also
implemented its benefit-risk framework across the total product life
cycle (TPLC), including the submission and review of IDE applications,
requests
[[Page 15624]]
for a Breakthrough Device designation, PMAs, HDE applications, De Novo
requests, and 510(k)s, and other FDA decisions involving
administrative, enforcement, and other actions. This update of the 2016
PPI Guidance reflects this TPLC scope as well as developments in the
field of health preference research. This final guidance fulfills a
commitment in Section V.E. of the Medical Device User Fee Amendments
Performance Goals and Procedures, Fiscal Years 2023 Through 2027 (MDUFA
V) to update the 2016 PPI Guidance with pragmatic insights and to
address common questions for those interested in the use of PPI in
regulatory submissions. This guidance supersedes the 2016 PPI Guidance
issued on August 24, 2016.
FDA considered the applicability of Executive Order 14192, per
Office of Management and Budget (OMB) guidance in M-25-20, and finds
this action to be neither regulatory nor deregulatory.
A notice of availability of the draft guidance appeared in the
Federal Register of September 6, 2024 (89 FR 72856). FDA considered
comments received and revised the guidance as appropriate in response
to the comments, including clarifying terminology, adding
recommendations on when sponsors may find it helpful to meet with FDA,
and adding recommendations on when patient engagement during the design
and implementation of a study may be beneficial.
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 Incorporating Voluntary Patient Preference
Information over the Total Product Life Cycle. 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, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics. Persons unable to download an electronic copy of
``Incorporating Voluntary Patient Preference Information over the Total
Product Life Cycle'' may send an email request to [email protected] to receive an electronic copy of the document.
Please use the document number GUI01500006 and complete title to
identify the guidance you are requesting.
III. Paperwork Reduction Act of 1995
While this guidance contains no new collection of information, it
does refer to previously approved FDA collections of information. The
previously approved collections of information are subject to review by
OMB under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521).
The collections of information in the following table have been
approved by OMB:
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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 Use 0910-0332
Devices;
Humanitarian
Device Exemption.
812............................. Investigational 0910-0078
Device Exemption.
860, subpart D.................. De Novo 0910-0844
classification
process.
``Requests for Feedback and Q-submissions and 0910-0756
Meetings for Medical Device Early Payor
Submissions: The Q-Submission Feedback Request
Program''. Programs for
Medical Devices.
800, 801, 809, and 830.......... Medical Device 0910-0485
Labeling
Regulations;
Unique Device
Identification.
50, 56.......................... Protection of Human 0910-0130
Subjects and
Institutional
Review Boards.
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Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-06063 Filed 3-27-26; 8:45 am]
BILLING CODE 4164-01-P