The FDA is introducing a new, voluntary program for certain medical devices and device-led combination products that are expected to significantly improve the safety of treatments for a disease or condition deemed less serious than those eligible for the breakthrough devices program.
Modeled on the breakthrough device program, the safer technologies program is expected to expedite development, assessment and review of these devices, the agency says. Devices and device-led combination products are eligible for this program if they are subject to review under a premarket approval application, de novo classification request, or 510(k).
The safer technologies program, or STeP, includes two phases. In the first phase, sponsors must request inclusion in STeP through a Q-submission. The second phase includes the prioritized review of subsequent regulatory submissions. The program is similar to the breakthrough device program in that it aims for timely communication, review team support and prioritized reviews, the agency says.
Read the agency’s draft guidance on safer technologies here: www.fdanews.com/09-26-19-SaferTechsProgramGuidance.pdf.