FDA releases final guidance on Breakthrough Devices Program

The FDA has issued a final guidance on its Breakthrough Devices Program, which is intended to provide patients and healthcare providers with timely access to medical devices for diagnosis and treatment of life-threatening or irreversibly debilitating conditions and diseases.  

The final guidance outlines program policies, features and the process for manufacturers when pursuing the breakthrough designation, according to a recent FDA news release. 

Specifically, the goal of the Breakthrough Devices Program is to provide patients and health care providers with timely access to these medical devices by speeding up their development, assessment, and review—while preserving the statutory standards for pre-market approval, 510(k) clearance and De Novo marketing authorization—consistent with the FDA's mission to protect and promote public health.  

“As part of gaining the Breakthrough designation, the sponsors developing these novel devices receive early and more frequent engagement with the FDA,” according to a recent statement from FDA Commissioner Scott Gottlieb, MD, and Jeff Shuren, MD, director of the Center for Devices and Radiological Health.

“This more collaborative process helps to make the development and review process more efficient and to facilitate generation of robust evidence required to support product marketing authorizations, while maintaining the quality of our review and ensuring that our review standards are met,” Gottlieb said in the same statement. 

The final guidance outlines various program options to better address device development topics as they arise, such as sprint discussions—meetings between the FDA and sponsors who need timely resolution of specific issues such as testing protocols—requests for feedback on a data development plan and requests for clinical protocol agreements. 

The FDA will also be hosting an hour and a half webinar on Thursday, Jan. 17, to clarify the Breakthrough Devices Program final guidance for manufacturers.  

“These options improve the efficiency of the FDA’s review resources and are designed to facilitate entry of state-of-the-art medical technologies to the market without compromising the standards for marketing authorization,” Gottlieb and Shuren wrote.  

The Breakthrough Devices Program replaces the FDA’s Expedited Access Pathway and Priority Review for medical devices. Medical devices granted designation under the Expedited Access Pathway are considered by the FDA to be part of the Breakthrough Devices Program.  

Since the Breakthrough Devices Program was authorized in late 2016 and added to the 21st Century Cures Act, a total of 110 devices have received the designation and eight have received marketing authorization.