Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Health Care Draft Guidance for Industry and Food and Drug Administration Staff October 2022
Not for implementation. Contains non-binding recommendations.
- Docket Number:
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Guidance Issuing OfficeCenter for Devices and Radiological HealthCenter for Biologics Evaluation and Research
FDA has developed this draft guidance to propose select updates to the FDA guidance document “Breakthrough Devices Program Guidance for Industry and Food and Drug Administration Staff”. This guidance proposes select updates to the guidance that clarify how the program may be applicable to certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions in populations impacted by health and/or health care disparities. The existing guidance on the Breakthrough Devices Program remains in effect, in its current form, until this draft guidance is finalized.
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:
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-2022-D-1061.