Devices

Medical Device Study Patient Engagement Guidance

David McFarland

— 1 min read
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FDA has published a guidance, Patient Engagement in the Design and Conduct of Medical Device Clinical Studies, on the value of patient and caregiver experiences and perspectives to medical device studies. The document is intended to: 

  •          help sponsors understand how they can voluntarily use patient engagement to elicit experience, perspectives, and other relevant information from patient advisors to improve the design and conduct of medical device clinical studies;
  •          highlight the benefits of engaging with patient advisors early in the medical device development process;
  •          illustrate which patient engagement activities are generally not considered by FDA to constitute research or an activity subject to agency regulations; and
  •          address common questions and misconceptions about collecting and submitting to FDA patient engagement information about the design and conduct of a medical device clinical study.

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