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FDA to Focus on Equity in Breakthrough Medical Device Reviews

Oct. 20, 2022, 7:06 PM

The FDA plans to consider in its review of breakthrough medical devices whether a product is designed to target traditionally underrepresented groups, the agency announced Thursday.

New draft guidance from the Food and Drug Administration intends to update 2018 recommendations on the agency’s Breakthrough Devices Program, a voluntary initiative by the FDA aimed at giving patients more timely access to certain devices and device-led combination products that offer more effective treatment or diagnosis of life-threatening or debilitating diseases.

The changes are part of the Center for Devices and Radiological Health’s strategic priority to advance health equity over the next few ...