Safer technologies program finalized by FDA

Newly finalized guidance from the FDA aims to make it easier for device manufacturers to improve the safety of existing treatment and diagnostic options for certain diseases and conditions. The Safer Technologies Program for Medical Devices (STeP) is intended for devices and combination products that target conditions that are less serious than those covered by FDA’s Breakthrough Devices Program, after which it is modeled. To qualify for STeP, devices should “significantly improve the benefit-risk profile of a treatment or diagnostic through substantial safety innovations,” FDA said. Specific benchmarks that show benefit-risk improvement include reductions in known serious adverse events and device failure modes, reductions in a known use-related hazard or error, and making another device or intervention safer. A draft version of the guidance was made public in September 2019. Public comments on the draft guidance led FDA to clarify the scope of the program by and the review time frame. The final guidance also clarifies that statutory requirements for medical device marketing authorizations still apply, and that FDA must still use “least burdensome” policies and approaches.