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USA: FDA Drafts Guidance on Patient Engagement in Device Trials


The US Food and Drug Administration (FDA) has published draft guidance on how device manufacturers

should engage patients when designing medical devices. 

This Draft Guidance is Intended to:

  • Help sponsors understand how they can use patient engagement to elicit experience, perspectives, and other relevant information from patient advisors to improve the design and conduct of clinical investigations;
  • 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 the FDA to constitute research or activity subject to FDA’s regulations, including regulations regarding institutional review boards (IRBs); and
  • Address common questions and misconceptions about collecting and submitting to FDA patient engagement information.