The US Food and Drug Administration (FDA) released draft guidance to introduce a new, voluntary program for certain medical devices and device-led combination products that are expected to improve the safety of currently available treatments or diagnostics but are used for morbidities and mortalities less serious than those eligible for the Breakthrough Devices Program.
Devices that may be included in this Safer Technologies Program” or “STeP” may include those treating or diagnosing non-life-threatening or reasonably reversible conditions, the 21-page draft says.
Similar to the Breakthrough Devices Program, STeP is comprised of two phases where interested sponsors formally request inclusion in STeP through a Q-submission and where FDA takes action to expedite the development of the device and the prioritized review of subsequent regulatory submissions.
For devices accepted into STeP, FDA intends to provide early and regular interactions and timely communication with the sponsor during device development and throughout the review process. FDA also says that it intends that the reviews for devices in STeP are prioritized in the appropriate review queue “as resources permit and receive additional review resources, as available.”
But the draft also notes that review times may take longer for devices accepted into STeP than for other devices because technological or design innovations may raise novel scientific issues.
Devices that would be eligible for STeP would not be eligible for the breakthrough devices program but, FDA says,
“should be reasonably expected to significantly improve the benefit-risk profile of a treatment or diagnostic through substantial safety innovations that provide for one or more of the following: a. a reduction in the occurrence of a known serious adverse event, b. a reduction in the occurrence of a known device failure mode, c. a reduction in the occurrence of a known use-related hazard or use error, or d. an improvement in the safety of another device or intervention.”
Each of these factors is explained further in the draft. The draft also outlines in an appendix the recommended information that should be included in a Q-submission requesting inclusion in STeP.