Safer technologies program finalized by FDA
A newly finalized guidance from the US Food and Drug Administration (FDA) smooths the path for manufacturers of devices and device-led combination products that stand 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.
In addition to addressing less-serious disease and conditions – such as those that are treatable, or that will not lead to loss of life if untreated – devices qualifying for STeP should “significantly improve the benefit-risk profile of a treatment or diagnostic through substantial safety innovations,” said FDA in the guidance. (RELATED: Not quite a breakthrough device, FDA introduces new safer technologies program, Regulatory Focus 18 September 2019)
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, or, finally, making another device or intervention safer.
“FDA believes that this [program] will help patients have more timely access to these medical devices and device-led combination products by expediting their development, assessment, and review, while preserving the statutory standards for premarket approval, De Novo marketing authorization, and 510(k) clearance,” noted the agency in the Federal Register announcement of the finalization of the guidance.
The guidance includes an appendix with an illustrative example of what a Q-submission request for STeP inclusion should look like.
A draft version of the guidance was made public in September 2019; public comments on the draft guidance led FDA to clarify the scope of the program by providing additional examples of the types of devices that could fall under the STeP program, as well as clarifying the review time clock. Also, the final guidance makes clear that statutory requirements for medical device marketing authorizations still apply, and that FDA must still use “least burdensome” policies and approaches.
FDA