Patient Engagement in the Design and Conduct of Medical Device Clinical Investigations; Draft Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders; Availability

摘要

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Patient Engagement in the Design and Conduct of Medical Device Clinical Investigations." The Patient Engagement Advisory Committee (PEAC) recommended that FDA and industry develop some type of framework to clarify how patient advisors can engage in the clinical investigation process. This draft guidance focuses on the applications, perceived barriers, and common challenges of patient engagement in the design and conduct of medical device clinical investigations. This draft guidance is not final nor is it in effect at this time.