Patient Engagement in the Design and Conduct of Medical Device Clinical Studies

On 26 January 2022 the FDA issued the final guidance for industry, FDA staff, and other stakeholders.

FDA is pursuing various efforts for encouraging voluntary patient engagement in clinical studies, including issuing this guidance. FDA believes medical device clinical studies designed with input from diverse patient advisors, including those from racially and ethnically diverse populations, may help to address common challenges faced in these clinical studies.

While FDA acknowledges that patient engagement may be beneficial across the total product lifecycle, this guidance focuses on the application of patient engagement in the design and conduct of medical device clinical studies.

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