> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Breakthrough Device Guidance Updates
- URL: https://www.fdaweb.com/breakthrough-device-guidance-updates/
- Published: 2022-10-20T12:00:00.000Z
- Updated: 2026-09-14T18:03:48.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5153019

FDA has published a draft guidance, *Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Healthcare*, to propose select updates to the Breakthrough Devices Program guidance. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/select-updates-breakthrough-devices-program-guidance-reducing-disparities-health-and-health-care?utm%5Fmedium=email&utm%5Fsource=govdelivery) says the existing guidance remains in use in its current form until this draft is finalized.

“FDA intends to incorporate the updates proposed in this draft guidance into one final guidance document after obtaining and considering public comment on these proposed select updates,” the guidance says.

The agency says it is proposing updates to the guidance to clarify how the breakthrough devices program may be applicable to certain devices that benefit populations affected by health and/or healthcare disparities, which would include adding clarifying language to the guidance’s Introduction.

FDA also is proposing to update the guidance to state in the Introduction that certain non-addictive medical products to treat pain or addiction may be eligible for the program.

Updates also are proposed to clarify the designation considerations for the first criterion of the law, as well as to add new information about FDA’s intent to disclose the breakthrough device designation of designated devices once they obtain marketing authorization for use consistent with their breakthrough device designation.