Posted by Michael Wonder on 18 Sep 2019
FDA continues steps to promote innovation in medical devices that help advance patient safety through the Safer Technologies Program
18 September 2019 - Today, the Food and Drug Administration issued draft guidance titled “Safer Technologies Program for Medical Devices,” a voluntary program that is expected to significantly improve the safety of available treatments or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 modelled after the Breakthrough Devices Program.
