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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Rockville, MD 20852

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