[Federal Register Volume 85, Number 169 (Monday, August 31, 2020)]
[Notices]
[Pages 53820-53822]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-19094]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-1564]


Principles for Selecting, Developing, Modifying, and Adapting 
Patient-Reported Outcome Instruments for Use in Medical Device 
Evaluation; Draft Guidance for Industry, Food and Drug Administration 
Staff, and Other Stakeholders; Availability

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of the draft guidance entitled ``Principles for 
Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome 
Instruments for Use in Medical Device Evaluation.'' The FDA encourages 
the collection, analysis, and integration of patient perspectives in 
the development, evaluation, and surveillance of medical devices, 
including digital health technologies. Patient-reported outcome (PRO) 
instruments facilitate the systematic collection of patient 
perspectives as scientific evidence to support the regulatory and 
healthcare decision-making process. This draft guidance describes 
principles that should be considered when using PRO

[[Page 53821]]

instruments in the evaluation of medical devices and provides 
recommendations about the importance of ensuring the measures are 
``fit-for-purpose.'' This draft guidance is not final nor is it in 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DATES: Submit either electronic or written comments on the draft 
guidance by October 30, 2020 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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-2020-D-1564 for ``Principles for Selecting, Developing, Modifying, 
and Adapting Patient-Reported Outcome Instruments for Use in Medical 
Device Evaluation.'' 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 
``Principles for Selecting, Developing, Modifying, and Adapting 
Patient-Reported Outcome Instruments for Use in Medical Device 
Evaluation'' 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: 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

    A PRO instrument can be used in a clinical investigation to measure 
the effects of a medical intervention or changes in the health status 
of a patient. PRO instruments allow for collection of certain data as 
evidence of safety and effectiveness which is complementary to other 
clinical outcomes and/or biomarkers. Information from well-defined and 
reliable PRO instruments can provide valuable evidence for benefit-risk 
assessments and can be used in medical device labeling to communicate 
the effect of a treatment on patient symptoms, functioning, or quality 
of life when the labeling is consistent with the PRO instrument's 
documented measurement capability. PRO instruments may be used to 
inform a patient's eligibility for inclusion within a study, to capture 
safety or effectiveness outcomes, and may be aligned as primary or 
secondary endpoints or used as a stand-alone outcome assessment or 
component of a composite endpoint. FDA determines the validity evidence 
needed to support use of a PRO instrument for a particular regulatory 
purpose informed by the way it is used in the clinical investigation. 
FDA uses the term ``fit-for-purpose'' to describe this flexible 
approach. In addition to providing evidence to assess the safety and 
effectiveness of medical devices, PRO instruments can measure the 
impact of medical devices on patient well-being and other concepts that 
may influence payers, healthcare providers, and patients when making 
decisions about potential treatments or management options.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115).

[[Page 53822]]

The draft guidance, when finalized, will represent the current thinking 
of FDA on ``Principles for Selecting, Developing, Modifying, and 
Adapting Patient-Reported Outcome Instruments for Use in Medical Device 
Evaluation.'' 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/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. 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 ``Principles for Selecting, Developing, 
Modifying, and Adapting Patient-Reported Outcome Instruments for Use in 
Medical Device Evaluation'' may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. 
Please use the document number 18042 to identify the guidance you are 
requesting.

III. 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. 3501-3521). The collections of information in 
the following FDA regulations and guidance have been approved by OMB as 
listed in the following table:

------------------------------------------------------------------------
                                                            OMB control
    21 CFR part or guidance               Topic                 No.
------------------------------------------------------------------------
807, subpart E.................  Premarket notification.       0910-0120
814, subparts A through E......  Premarket approval.....       0910-0231
814, subpart H.................  Humanitarian Device           0910-0332
                                  Exemption.
812............................  Investigational Device        0910-0078
                                  Exemption.
``De Novo Classification         De Novo classification        0910-0844
 Process (Evaluation of           process.
 Automatic Class III
 Designation)''.
``Requests for Feedback on       Q-submissions..........       0910-0756
 Medical Device Submissions:
 The Pre-Submission Program and
 Meetings with Food and Drug
 Administration Staff''.
800, 801, and 809..............  Medical Device Labeling       0910-0485
                                  Regulations.
------------------------------------------------------------------------


    Dated: August 21, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-19094 Filed 8-28-20; 8:45 am]
BILLING CODE 4164-01-P


