Notice2024-20069
Incorporating Voluntary Patient Preference Information Over the Total Product Life Cycle; Guidance for Industry, Food and Drug Administration Staff and Other Interested Parties; Availability
Primary source
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Published
September 6, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle." This draft guidance explains the principal concepts that sponsors and other interested parties should consider when choosing to collect and submit patient preference information (PPI). The knowledge gleaned from the use of PPI could be used across the total product life cycle, including for review in investigational device exemption (IDE) applications, premarket approval (PMA) applications, humanitarian device exemption (HDE) applications, De Novo classification requests, or premarket notifications (510(k)s). This draft guidance also discusses FDA's inclusion of PPI in its decision summaries and provides recommendations for the inclusion of such information in device labeling for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. This draft guidance is not final nor is it for implementation at this time.
Full Text
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<title>Federal Register, Volume 89 Issue 173 (Friday, September 6, 2024)</title>
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[Federal Register Volume 89, Number 173 (Friday, September 6, 2024)]
[Notices]
[Pages 72856-72858]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-20069]
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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the availability of the draft guidance entitled ``Incorporating
Voluntary Patient Preference Information over the Total Product Life
Cycle.'' This draft guidance explains the principal concepts that
sponsors and other interested parties should consider when choosing to
collect and submit patient preference information (PPI). The knowledge
gleaned from the use of PPI could be used across the total product life
cycle, including for review in investigational device exemption (IDE)
applications, premarket approval (PMA) applications, humanitarian
device exemption (HDE) applications, De Novo classification requests,
or premarket notifications (510(k)s). This draft guidance also
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. This draft guidance is not final nor is
it for implementation at this time.
DATES: Submit either electronic or written comments on the draft
guidance by December 5, 2024 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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'').
[[Page 72857]]
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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
``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. 5431, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
request.
FOR FURTHER INFORMATION CONTACT: David Gebben, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1316, Silver Spring, MD 20993-0002, 301-796-6461 or
James Myers, 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
FDA is announcing the availability of a draft guidance entitled
``Incorporating Voluntary Patient Preference Information over the Total
Product Life Cycle.'' 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 draft guidance proposes expanded recommendations to 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. In addition, FDA has cohosted or
participated in numerous convenings and international collaborations to
advance scientific methods and practical applications of PPI.
Meanwhile, FDA has expanded its benefit-risk guidance framework to
apply to the total product life cycle, including the submission and
review of IDE applications, 510(k)s, PMAs, De Novo requests, and HDEs
applications, and FDA decisions involving administrative, enforcement,
and other actions. This expansion of the 2016 PPI Guidance is intended
to reflect this broadened scope as well as developments in the field of
health preference research.
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
``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 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 <a href="https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products">https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products</a>. This guidance document is also
available at <a href="https://www.regulations.gov">https://www.regulations.gov</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a> or <a href="https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics">https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics</a>. 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 <a href="/cdn-cgi/l/email-protection#387b7c6a70157f4d515c59565b5d785e5c591650504b165f574e"><span class="__cf_email__" data-cfemail="d69592849efb91a3bfb2b7b8b5b396b0b2b7f8bebea5f8b1b9a0">[email protected]</span></a> to receive an electronic copy of the document.
Please use the document number GUI01500006 and complete title to
[[Page 72858]]
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
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (PRA) (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 Feedback
Submissions: The Q-Submission Request Programs for
Program''. 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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Dated: August 30, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-20069 Filed 9-5-24; 8:45 am]
BILLING CODE 4164-01-P
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