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Thursday, 01/18/2024 11:03:21 AM

Thursday, January 18, 2024 11:03:21 AM

Post# of 175388
What are the benefits of the Breakthrough Devices Program?
The Breakthrough Devices Program offers manufacturers an opportunity to interact with FDA experts through several different program options to efficiently address topics as they arise during the premarket review phase. This interaction can help manufacturers receive feedback from the FDA and identify areas of agreement in a timely way. Manufacturers can also expect prioritized review of their submission. Learn more about the Breakthrough Devices Program principles and features in Sections II and IV of the Breakthrough Devices Program final guidance.
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