On December 18, 2018 the Food and Drug Administration (“FDA”) finalized guidance on its existing Breakthrough Device Program and announced plans for advancement of the Safer Technologies Program (“STeP”). In the announcement, FDA Commissioner Scott Gottlieb emphasized the FDA’s efforts to promote innovation in medical devices that advance patient safety. This new medical device guidance could signal a year of opportunity for innovative medical device manufacturers that seek to advance patient safety.

Breakthrough Device Program

The Breakthrough Device program was created under the 21st Century Cures Act and seeks to facilitate the development and expedite the review of breakthrough technologies that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. Medical devices and device-led combination products that qualify for this program must meet specific criteria. First, the device must provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human diseases or conditions. Second, the device must meet at least one of the following criteria: (1) represent a breakthrough technology, (2) no approved or cleared alternatives exist, (3) offer significant advantages over existing approved or cleared alternatives, or (4) device availability is in the best interest of patients. A manufacturer can send a breakthrough designation request at any time prior to sending its marketing submission. The Breakthrough Devices program replaces the Expedited Access Pathway and Priority Review for medical devices.

Safer Technologies Program (“STeP”)

STeP was first revealed in the Medical Device Safety Action Plan published in April 2018. The purpose of the program is to serve as an alternative for devices that cannot or do not fit into the breakthrough device construct, but still seek to make current treatments or diagnostics significantly safer. The FDA anticipates creating guidelines for the STeP in 2019.

Opportunities for Stakeholders

The objective of both programs is to improve development through providing opportunity for additional interactions with FDA and faster reviews through a priority review designation and/or improving alignment on device development prior to regulatory marketing submissions. These features can provide value to device manufacturers, and potentially accelerate development, although they are not a substitute for a manufacturer’s own planning regarding regulatory strategy. Since its implementation in late 2016, approximately 110 devices have received Breakthrough Designation, so more manufacturers continue to take advantage of this program. The STeP program could create even more opportunities.

On January 17, 2019, the FDA will host a webinar to help clarify the Breakthrough Devices program’s final guidance for manufacturers. Manufacturers should view this webinar to become better acquainted with the program and consider its potential benefits to products in development.