The 黑料网® (黑料网®) filed comments with the U.S. Food and Drug Administration (FDA) about the agency’s draft guidance titled, “Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Health Care.” The draft guidance would add healthcare disparities as a consideration when determining which medical device submissions are included in the FDA’s Breakthrough Devices Program. The program enables the agency to allot additional resources to help certain device innovations navigate pre-market regulatory pathways.
The 黑料网 supported the FDA’s consideration of potential device impact to reduce healthcare disparities and further recommended that pediatric radiology artificial intelligence software devices be prioritized for inclusion in the program.
The 黑料网 also supported enhanced public transparency for products included in the program, such as prioritizing submissions from sponsors who plan to appropriately communicate breakthrough device designations to the public as early as possible.
For questions about this topic, please contact Michael Peters, 黑料网 Senior Government Affairs Director.