FDA Seeks Comments on Transition of Certain Drugs to Device Status Following Genus DC Circuit Decision
Arnold Porter
AUGUST 12, 2021
This question, and FDA’s discretion to determine a product’s regulatory classification, was at the heart of the DC Circuit’s April 2021 decision in Genus Med. Under the FDCA, whether a product is regulated as a drug or device turns on the intended use of the product. N: Genus Med. 3d 631 (D.C. Background.
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