> ## Content Index
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# Guide on Device Patient-Reported Outcome Instruments
- URL: https://www.fdaweb.com/guide-on-device-patient-reported-outcome-instruments/
- Published: 2020-08-28T12:00:00.000Z
- Updated: 2026-09-14T16:26:59.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5147539

FDA has issued a [draft guidance](http://s2027422842.t.en25.com/e/er?utm%5Fcampaign=2020-08-28%20PRO%20Guidance%20and%20Workshop&utm%5Fmedium=email&utm%5Fsource=Eloqua&s=2027422842&lid=15160&elqTrackId=B50FB22722B08026AB75CB71E08FC5E1&elq=d0d0219865e54fe58ec2a14421d0c920&elqaid=13975&elqat=1) on *Principles for Selecting, Developing, Modifying and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation*. The document discusses best practices for incorporating patient-reported outcome (PRO) instruments throughout a medical device’s lifecycle. It touches on the qualities of PRO instruments that are “relevant, reliable, and sufficiently robust to capture outcomes of importance to patients, regulators, and others in the health care community.” And it provides recommendations for less burdensome ways to develop PRO instruments such as modifying existing well-defined and reliable instruments for new contexts of use.