Safer Technologies Program for Medical Devices: Draft Guidance and Webinar

Today, the U.S. Food and Drug Administration (FDA) issued a draft guidance outlining the vision for the Safer Technologies Program for Medical Devices. Once the guidance is finalized, the program will be a voluntary pathway for certain medical devices that is expected to significantly improve the safety of currently available treatments or diagnostic devices for diseases or conditions that are less serious than those eligible for the Breakthrough Devices Program, but the use of which may be associated with serious or life-threatening risks.

Read the Draft Guidance Upcoming Webinar on the Safer Technologies Program Draft Guidance On November 6, 2019, the FDA will host a webinar on the Safer Technologies Program for industry and others interested in learning more about the Program and draft guidance. Registration is not necessary. Submit Comments on the Draft Guidance The draft guidance will be open for public comment for 60 days, through November 18, 2019, at www.regulations.gov under docket number FDA-2019-D-4048.  Questions? If you have questions about the guidance, contact the Division of Industry and Consumer Education.