FDA proposes updates to breakthrough devices guidance focused on reducing disparities in healthcare

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The U.S. Food and Drug Administration (FDA) on Thursday issued a draft guidance that proposes updates to clarify how its Breakthrough Devices Program may be applicable to certain medical devices that promote health equity.

The Breakthrough Devices Program is a voluntary program for certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases.

The new guidance, called "Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Health Care,"  also proposes updates to clarify considerations in designating devices, including eligible devices that may benefit populations impacted by disparities in healthcare, the FDA said.

Additionally, the document proposes updates to clarify how the agency discloses the breakthrough status of designated devices when they receive marketing authorization.

“This draft guidance, once finalized, can help FDA and our stakeholders leverage the interactive nature of the Breakthrough Devices Program to move us closer to achieving our new strategic priority to advance health equity, where technologies, including digital health technologies, can help advance better healthcare, quality of life, and wellness for all communities, and meet the needs of diverse populations,” Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement.

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