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Devices Addressed In US FDA's New Regenerative Medicine Framework

 
• By Elizabeth Orr

The framework includes two draft guidance documents and two final guidances. One of the drafts, which focuses on the regulation of devices used with regenerative medicine, implements a provision of the 21st Century Cures Act and strongly suggests that most of these products will be regulated via class II.

Scientist

Draft guidance from US FDA on devices used to support Regenerative Medicine Advanced Therapy (RMAT) products outlines a risk-based approach that would allow different devices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...

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