Medical Device PRO Guidance

FDA has published a guidance, Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation, to help facilitate the systematic collection of how patients feel, function, and survive as valid scientific evidence to support the regulatory and healthcare decision-making process. The document objectives are to: 

•          describe principles that may be considered when using patient-reported outcome (PRO) instruments in the evaluation of medical devices;
•          provide recommendations about the importance of ensuring the PRO instruments are fit-for-purpose; and
•          outline best practices to help ensure relevant, reliable, and sufficiently robust PRO instruments are developed, modified, or adapted using the least burdensome approach.

FDA says the guidance is not meant to replace the Patient-Focused Drug Development guidance series led by CDER and CBER.