This guidance document describes policies that FDA intends to use to implement section 515B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360e-3), as created by section 3051 of the 21st Century Cures Act (Cures Act) (Public Law 114-255) and amended by section 901 of the FDA Reauthorization Act of 2017 (Public Law 115-52) (the “Breakthrough Devices Program”). 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. It is available for devices and device-led combination products which are subject to review under a premarket approval application (PMA), premarket notification (510(k)), or De Novo classification request (“De Novo request”). 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, 510(k) clearance, and De Novo marketing authorization, consistent with the Agency’s mission to protect and promote public health.

The Breakthrough Devices Program supersedes the Expedited Access Pathway (EAP), which was launched in 2015. The Breakthrough Devices Program contains features of the EAP as well as the Innovation Pathway (first piloted in 2011; the pilot is now discontinued), both of which were intended to facilitate the development and expedite the review of breakthrough technologies. Due to consistency in vision and designation criteria between the precursor EAP Program and the Breakthrough Devices Program, FDA now considers devices granted designation under the EAP to be part of the Breakthrough Devices Program.

The Breakthrough Devices Program also supersedes the Priority Review Program, which implemented statutory criteria for granting priority review to premarket submissions for medical devices and included standard procedures to achieve an efficient priority review process. However, consistent with Section 515B of the FD&C Act, devices designated as Breakthrough Devices will receive prioritized review (Section II.F).