Division of Clinical Research

Office of the Vice President and Innovation

The U.S. Food and Drug Administration (FDA) issued final guidance outlining the Safer Technologies Program (STeP) for Medical Devices. This program will be 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.

In addition, the FDA updated the final guidance “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program” to include that a Q-submission is the appropriate mechanism for submission of requests for inclusion in STeP, as well as other minor updates.

The FDA does not intend to accept requests for inclusion in the program within this time period but anticipates accepting program entrance requests beginning on March 8, 2021.

Read the full guidance here: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safer-technologies-program-medical-devices?utm_medium=email&utm_source=govdelivery

Categories FDA Regulatory, Policies & Guidance
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