A divisive ruling on devices — Genus Medical Technologies v. FDA

New England Journal of Medicine

24 November 2021 - The FDA has long taken the legal position that regulated devices could also be categorised as drugs. 

But according to a recent case, products meeting the definition of a device “must be regulated as devices.” 

The decision comes amid growing challenges to FDA authority.

Read New England Journal of Medicine Perspective

Michael Wonder

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Michael Wonder

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US , Regulation , Device