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US FDA’s Reclassification Of Certain Drugs As Devices May Be 'Seismic Event' For Some

 
• By Brenda Sandburg

Sponsors are receiving information requests and complete response letters as a result of the agency’s transition plan, which was made in response to the Genus v. FDA ruling. The decision's aftershocks could reshape the landscape for a number of products, attorney says.

Seismic wave
Court ruling on drug-device classification has potential to be seismic event • Source: Alamy

The US Food and Drug Administration’s plan to transition certain products regulated as drugs to device status could have significant repercussions for the pharmaceutical industry. While the agency is focusing on whether imaging agents meet the device definition, it is also reexamining other product categories as well. Sponsors have already received complete response letters and notices of deficiencies in their applications as a result of the reclassification.

In August, the agency announced in a Federal Register notice that it would be publishing a list of approved drug products it tentatively determines should transition to device status in accordance with the US Court of Appeals for the District of Columbia Circuit’s decision in Genus Medical Technologies LLC v. FDA

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