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Draft Guidance for Industry and Food and Drug Administration Staff, And Other Stakeholders
The objectives of this guidance are to:
- Describe principles that may be considered when using PRO instruments in the evaluation of medical devices (Section III);
- Provide recommendations about the importance of ensuring the PRO instruments are fit-for-purpose (Section III), and;
- 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)