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# Guide on Device Patient-reported Outcomes Usage
- URL: https://www.fdaweb.com/guide-on-device-patient-reported-outcomes-usage/
- Published: 2020-08-31T12:00:00.000Z
- Updated: 2026-09-14T16:27:09.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5147545

*Federal Register* notice: FDA has made available a draft guidance entitled *Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation*. FDA says patient-reported outcome (PRO) instruments facilitate the systematic collection of patient perspectives as scientific evidence to support regulatory and healthcare decision-making process. The document describes principles that should be considered when using PRO instruments in evaluating medical devices and provides recommendations about the importance of ensuring the measures are “fit-for-purpose.” To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2020-08-31/pdf/2020-19094.pdf?ref=fdaweb.com).