15 Apr Principles for Selecting, Developing, Modifying, and Adapting PatientReported Outcome Instruments for Use in Medical Device Evaluation

Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation

Draft Guidance for Industry and Food and Drug Administration Staff, And Other Stakeholders

August 2020

The objectives of this guidance are to:

1. Describe principles that may be considered when using PRO instruments in the evaluation of medical devices (Section III);
2. Provide recommendations about the importance of ensuring the PRO instruments are fit-for-purpose (Section III), and;
3. Outline best practices to help ensure relevant, reliable, and sufficiently robust PRO instruments are developed, modified, or adapted using the least burdensome approach (Section IV).

U.S. FOOD & DRUG Admnistration (FDA)