Breakthrough Devices Program: guidance for industry and Food and Drug Administration staff
- Collection:
- Health Policy and Services Research
- Contributor(s):
- Center for Devices and Radiological Health (U.S.), issuing body. Center for Biologics Evaluation and Research (U.S.), issuing body.
- Publication:
- Silver Spring, MD : Center for Devices and Radiological Health, September 15, 2023
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Data Collection Device Approval Government Regulation Medical Device Legislation United States United States. United States.
- Genre(s):
- Guideline Technical Report
- Abstract:
- This guidance document describes policies that 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 Act4 (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. It is available for devices and device-led combination products which are subject to review under a premarket approval application (PMA), premarket notification (510(k)), or De Novo classification request (“De Novo request”). The Breakthrough Devices Program may also be applicable to certain devices that benefit populations impacted by health and/or health care disparities, thereby promoting and advancing health equity. In addition, consistent with our obligations under the SUPPORT Act, the Breakthrough Devices Program may 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 Devices Program is intended to help patients have more timely access to designated 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 mission9 to protect and promote public health.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (31 pages))
- NLM Unique ID:
- 9918716786606676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918716786606676