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GUIDANCE DOCUMENT

Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation Guidance for Industry and Food and Drug Administration Staff, And Other Stakeholders January 2022

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2020-D-1564
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research

FDA is issuing this guidance to describe principles that should be considered when using Patient-Reported Outcome (PRO) instruments in the evaluation of medical devices and provide recommendations about the importance of ensuring the measures are fit-for-purpose. This guidance is not meant to replace the Patient-Focused Drug Development (PFDD) guidance series.

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Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2020-D-1564.

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