Draft guidance from US FDA on devices used to support Regenerative Medicine Advanced Therapy (RMAT) products outlines a risk-based approach that would allow different devices to be approved via the PMA, 501(k) or de novo processes, as well as humanitarian device exemptions. But it offers few details on how the agency would determine which pathway was appropriate, saying the decisions will be made case-by-case.
The guidance was issued as part of a broader framework the agency rolled out Nov. 16 to streamline development of new regenerative medicine treatments, including stem cell treatments. As part...
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