The Breakthrough Devices Program is a voluntary program for certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. This program is intended to help patients have more timely access to these medical devices by expediting their development, assessment, and review, while preserving the statutory standards for premarket approval, clearance of a premarket notification
(510(k)), and marketing authorization via the De Novo classification process, consistent with the Agency’s mission1  to protect and promote public health.

 

Breakthrough Devices Program