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.
Take Our Quiz!

Is the Breakthrough Device Designation Right For Your Product?

Discover Now

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.

What are the benefits of this designation for my emerging company?

Pharmaceutical Regulatory Consulting
More communication with the FDA
Medical Device Regulatory Consulting
A more flexible clinical study design
Quality Management

Do you want to know what other emerging companies Proxima CRO works with has to say about their BDD submission experience?

Our experienced CRO consultants at Proxima have helped clients get this designation; hear what they want other companies investigating breakthrough device designation to know.

More Resources to Learn About Breakthrough Device Designation: