FDA Proposes Safer Technologies Program for Medical Devices


Posted September 25, 2019

The Food and Drug Administration’s (FDA) Center for Device and Radiological Health (CDRH) has published draft guidance that outlines a voluntary program for expediting the approval of promising treatments and diagnostics for non–life-threatening diseases.

The FDA’s vision for its proposed Safer Technologies Program (STeP) for Medical Devices is to help patients have more timely access to products expected to significantly improve safety by expediting their development, assessment, and review, while also “preserving the statutory standards for premarket approval, De Novo marketing authorization, and 510(k) clearance.”

These products include devices and device-led combinations for conditions that are less serious than those eligible for the agency’s Breakthrough Devices Program.

Products that will be eligible for STeP, intended to be modeled after the Breakthrough Devices Program, should reduce the occurrence of a known serious adverse event, device failure mode, and/or use-related hazard or use error, according to the FDA. A request to be included in the program is made through a Q-Submission. If an FDA review deems a product appropriate for STeP, the agency will engage its senior management to expedite device development and prioritize its review through regulatory submissions.

“Because technology continues to advance, patients are benefitting from more innovative medical devices that can help improve their health and even save their lives. Safety and innovation are both important priorities for the agency. Improvements in each of these areas are expected to result in increased quality of life and health benefits for patients, while simultaneously providing a reasonable assurance of both safety and effectiveness,” said CDRH Director Jeff Shuren.

The FDA is hosting a webinar on Nov. 6 to provide more information about the Safer Technologies Program and the draft guidance. The FDA is also accepting feedback on the draft guidance until Nov. 18 at www.regulations.gov (docket FDA-2019-D-4048).