- February 1, 2021
12:00 PM - 1:30 PM ET
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Summary: On Monday, Feburary 1, 2021, the FDA will host a webinar on the Safer Technologies Program for industry and other stakeholders interested in learning more about the Program and final guidance.
Background: The U.S. Food and Drug Administration (FDA) issued a final guidance outlining the Safer Technologies Program for Medical Devices. This program is a voluntary pathway for certain medical devices and device-led combination products that are reasonably expected to significantly improve the safety of currently available treatments or diagnostics for diseases or conditions that are less serious than those eligible for the Breakthrough Devices Program.
We recognize and anticipate that the FDA may need up to 60 days to operationalize the Safer Technologies Program following issuance of the final guidance. The FDA does not intend to accept requests for inclusion in the program within this time period. We anticipate accepting program entrance requests beginning on March 8, 2021.