MedTech Dive September 18, 2023
The proposals received positive feedback from groups including AdvaMed, leading the FDA to finalize the changes with only minor revisions.
Dive Brief:
- The Food and Drug Administration has finalized changes to its breakthrough devices guidance, adopting revisions that could accelerate development of products that address health inequities.
- Eleven months ago, the FDA proposed updating its breakthrough guidance to clarify that devices that improve accessibility, and thereby tackle health inequities, can qualify for the program.
- The proposals received broadly positive feedback, including from industry trade group AdvaMed, leading the FDA to finalize the changes with only minor revisions and schedule a webinar to discuss its new policy.
Dive Insight:
The FDA designed the breakthrough program to support...
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