Earlier on 21 October 2022, the USFDA released draft guidance "Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Health Care" for comment purposes.
The guidance proposes select updates to clarify how the program may apply to certain medical devices that improve the treatment or diagnosis of life-threatening or irreversibly debilitating diseases and conditions for populations with health and/or healthcare disparities.
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.
In accordance with the goals of the Breakthrough Devices Program and the statutory designation criteria, FDA is proposing updates to the Breakthrough Devices Program guidance. The purpose is to explain how the Breakthrough program may apply to certain devices that benefit populations with health disparities, which would include clarifying language in the guidance.
The existing guidance on the Breakthrough Devices Program remains in effect, in its current form, until this draft guidance is finalized.
Click this LINK to know more about how to reduce disparities in health & health care using this guidance.