Breakthrough Devices Program; Guidance for Industry and Food and Drug Administration Staff; Availability
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Breakthrough Devices Program." This final guidance describes policies that FDA intends to use to implement a section of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This guidance updates the previous version of the guidance, of the same title, issued on December 18, 2018, and describes how the Breakthrough Devices Program may also be applicable to certain devices that benefit populations impacted by health and/or healthcare disparities. Consistent with our obligations under the SUPPORT for Patients and Communities Act (SUPPORT Act), the Breakthrough Devices Program may be available for certain non-addictive medical products to treat pain or addiction.
Abstract as published in the Federal Register.
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