Breakthrough Device Designation
US-unique
The Breakthrough Device Designation programme was created by the 21st Century Cures Act (2016) and is a US-specific accelerated review programme.
What is Breakthrough Device Designation?
Breakthrough Device Designation provides manufacturers with the opportunity to interact more closely with FDA during device development and to obtain more efficient review of marketing submissions for:
- Devices intended to treat or diagnose life-threatening or irreversibly debilitating diseases or conditions; and
- Where the device provides for more effective treatment or diagnosis compared to currently available alternatives, or where no approved or cleared alternatives exist
Benefits of designation
- Priority review — the device receives expedited FDA review
- Early collaboration — more frequent and interactive communication with FDA during development
- Organizational commitment — FDA assigns senior staff to the review
- Cross-center coordination — for combination products, facilitates coordinated review
Breakthrough Designation does not lower the standard for approval — the device must still demonstrate safety and effectiveness through the applicable pathway (510(k), De Novo, PMA).
How to request designation
Submit a Breakthrough Device Designation Request to FDA:
- Can be submitted at any time during device development
- Should include: device description, intended use, target population, comparison to existing alternatives, and the basis for the claim of benefit
- FDA responds within 60 calendar days