Patient Engagement in the Design and Conduct of Medical Device Clinical Studies Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders January 2022
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Devices and Radiological HealthCenter for Biologics Evaluation and Research
FDA is pursuing various efforts of encouraging voluntary patient engagement in clinical studies, including guidance. FDA believes medical device clinical studies designed with patient input may help to address common challenges faced in medical device clinical studies. While FDA acknowledges that patient engagement may be beneficial across the total product lifecycle, this guidance focuses on the applications of patient engagement in the design and conduct of medical device clinical studies.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2019-D-3846.