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USA: FDA Drafts Guidance on Patient Engagement in Device Trials

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The US Food and Drug Administration (FDA) has published draft guidance on how device manufacturers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This Draft Guidance is Intended to: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.