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Breakthrough Devices Program Guidance for Industry and Food and Drug Administration Staff September 2023

Docket Number:
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research

FDA is issuing this guidance to describe the policies FDA intends to use to implement section 515B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360e-3), as created by section 3051 of the 21st Century Cures Act (Cures Act), amended by section 901 of the FDA Reauthorization Act of 2017, and amended by Section 3001 of the SUPPORT for Patients and Communities Act  (the SUPPORT Act) (the “Breakthrough Devices Program”). The Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The Breakthrough Devices Program may also be applicable to certain devices that benefit populations impacted by health and/or healthcare disparities. In addition, consistent with our obligations under the SUPPORT Act, the Breakthrough Devices Program may also be available for certain non-addictive medical products to treat pain or addiction (FD&C Act section 515B (21 U.S.C. 360e-3)). The Breakthrough Program is intended to help patients have more timely access to medical devices by expediting their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the Agency’s mission to protect and promote public health.

Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2017-D-5966.

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