What Is Breakthrough Device Designation For Medical Devices?
Take our quiz for innovators to find out if your treatment is groundbreaking.
Is your device a breakthrough device? The FDA’s breakthrough device designation has many benefits for an emerging super-star company, such as yourself. Learn what defines a breakthrough device.
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Is the Breakthrough Device Designation
Right For Your Product?
Right For Your Product?
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.
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.
