FDA In Brief: FDA continues steps to promote innovation in medical devices that help advance patient safety through the Safer Technologies Program

FDA In Brief: FDA continues steps to promote innovation in medical devices that help advance patient safety through the Safer Technologies Program

Today, the Food and Drug Administration  issued draft guidance titled “Safer Technologies Program for Medical Devices,” a voluntary program that is expected to significantly improve the safety of available treatments or diagnostic devices for diseases or conditions that are less serious than those eligible for the agency’s Breakthrough Devices Program, but the use of which may be associated with serious or life-threatening risks. The Safer Technologies Program, as described in our 2018 Medical Device and Safety Action Plan, aims to spur innovation towards safer medical devices and was modeled after the Breakthrough Devices Program. As agency resources permit, the Safer Technologies Program will include features such as ...

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