What is the FDA’s breakthrough
device designation?
The Breakthrough Device Designation (BDD) is a low-cost mechanism for certain medical devices that meet specific eligibility criteria determined by the FDA. The BDD may allow for more support from and communication with FDA, timelier interactions, a more flexible clinical study design, and priority review.
This frequent communication increases the efficiency of the development and review processes, allowing for a reduction in time to market for new and novel medical devices.
