CDRH and CBER Breakthrough Device Marketing Authorizations List

CDRH leads the way with the most products approved as this list notes of Breakthrough Device Marketing Authorizations. These guidances are related to the Breakthrough Devices Program:

Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program

Final Guidance: Breakthrough Devices Program 

Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications (Benefit Risk Final Guidance)

Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics – Guidance for Industry and Food and Drug Administration Staff