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January 14, 2022

FDA Considering Reclassifying Certain Drugs as Devices

In response to a 2021 decision by the U.S. Court of Appeals for the District of Columbia Circuit, FDA has begun to transition some approved products from drug status to device status. Going forward, FDA will regulate products as devices even though they may meet the definitions of both devices and drugs, This change includes products the FDAmay have previously classified differently except where Congress indicated through statute a different classification.

Interested parties are pushing back, arguing the decision should not apply retroactively and that the FDA lacked the legal authority to reclassify products that have been long regulated as drugs.  FDA, however, intends to publish a list of potentially affected drugs and offer a chance for comment before finalizing any decisions.