Patient-Reported Outcomes (PROs) in Medical Device Decision Making

This web page focuses on the use of patient-reported outcomes (PRO) as one type of patient input.

  • What Are Patient-Reported Outcomes
  • How CDRH Uses PROs in Regulatory Decision Making
  • CDRH Collaborations, Studies, Articles, and Workshops on Patient-Reported Outcomes
  • How to Incorporate Patient-Reported Outcome Measures (PROMs) in a Regulatory Submission


Image credit: FDA