FDA announces new expedited program for devices expected to significantly improve the safety of existing technologies

On 19 September 2019 the U.S. Food and Drug Administration (FDA or the agency) released the draft guidance document entitled "Safer Technologies Program for Medical Devices" (STeP), effectively following through on the agency's intention to spur innovation toward safer medical devices, as described in its 2018 Medical Device Safety Action Plan.

STeP is designed to be a voluntary program for medical devices and device-led combination products that offer a significant safety advantage compared to commercially available products. FDA envisions STeP as a complement to the Breakthrough Devices Program. Products that offer significant safety advantages, but otherwise do not meet the criteria for breakthrough status could be eligible for similar benefits through the STeP program.

Read More: FDA announces new expedited program for devices expected to significantly improve the safety of existing technologies


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