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FDA Takes Aim At Reducing Health Disparities Through Breakthrough Devices Program

 
• By Brian Bossetta

Proposed updates to the US FDA’s breakthrough devices program guidance would help to clarify how the program may be applicable to devices that treat and diagnose diseases that disproportionately affect certain populations.

Health Inequity
• Source: Shutterstock

The US Food and Drug Administration has issued a set of proposals intended to update the agency’s guidance on its breakthrough devices program, which is a voluntary program that allows enhanced review of medical devices that provide more effective treatment or diagnosis of life-threatening or debilitating diseases.

The proposals in the 21 October draft guidance "Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Health Care," are intended to update the agency’s...

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