CDRH’s updated final guidance on Breakthrough Devices Program

Advancements in science and technology offer extraordinary opportunities to develop innovative medical products that can save lives and lead to better diagnostics, better treatments, and better care for patients. The FDA is committed to advancing the public health by helping to bring innovative technologies to market and assuring that medical devices already on the market continue to be safe and effective.

The Breakthrough Devices Program reflects this commitment and the benefits of extensive engagement with industry as a means of bringing innovative products to patients in need. Launched in 2015, the program has expanded significantly and far exceeded expectations for Breakthrough Device designation requests and authorization volumes. As of June 30, 2023, CDRH has granted Breakthrough Device designation to 831 devices and granted marketing authorization to 77 devices with Breakthrough Device designation. These devices represent a wide range of intended uses and span regulatory pathways, highlighting the influence of this program throughout the Center.  

The Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The program is intended to provide patients and health care providers with timely access to medical devices by speeding up development, assessment, and review for premarket approval, 510(k) clearance, and De Novo marketing authorization. Breakthrough Devices must meet the FDA’s rigorous standards for device safety and effectiveness to be authorized for marketing.

• Read the full statement here
• Read the Breakthrough Devices Updated Guidance