The US Food and Drug Administration (FDA)  released new draft guidance explaining how sponsors can improve the design and conduct of medical device clinical investigations by using patient experience, perspectives and other relevant information.

This draft guidance is intended to: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 (see definition in Section IV) to improve the design and conduct of medical device 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 FDA toconstitute research or an activity subject to FDA’s regulations, including regulations regarding institutional review boards (IRBs)
  •  address common questions and misconceptions about collecting and submitting to FDA patient engagement information regarding the design and conduct of a medical device clinical investigation.

Patient Engagement in the Design and Conduct of Medical Device Clinical Investigations: Draft Guidance