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
Issued by:
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research

FDA (The Food and Drug Administration) 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.