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FDA Updates Breakthrough Devices Guidance Focused on Health Equity



The FDA has issued a new draft guidance: Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Health Care. 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The draft guidance proposes updates to clarify how the Breakthrough Devices Program may be applicable to certain medical devices that promote health equity. It also proposes updates to clarify considerations in designating devices, including eligible devices that may benefit populations impacted by disparities in health and health care, as well as how the FDA discloses the Breakthrough status of designated devices once they receive marketing authorization.

“The FDA is committed to advancing the development of safe and effective technologies to meet the needs of all patients and consumers. This draft guidance, once finalized, can help FDA and our stakeholders leverage the interactive nature of the Breakthrough Devices Program to move us closer to achieving our new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 health care, quality of life, and wellness for all communities, and meet the needs of diverse populations,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.

Stakeholders can submit comments on the draft guidance up to December 20, 2022. 

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