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  5. Webinar - Safer Technologies Program: Final Guidance - 02/01/2021 - 02/01/2021
  1. Workshops & Conferences (Medical Devices)

Webcast

Event Title
Webinar - Safer Technologies Program: Final Guidance
February 1, 2021


Date:
February 1, 2021
Time:
12:00 PM - 1:30 PM ET

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.

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Webinar Details:

Registration is not necessary.

Date: February 1, 2021
Time: 12:00 PM - 1:30 PM, ET

To ensure you are connected, please dial-in 15 minutes prior to the start of the webinar.

U.S. Callers Dial:

  • 888-455-1392
  • Conference Number: PWXW1929130
  • Passcode: 5640600

International Callers Dial:

  • 1-773-799-3847
  • Conference Number: PWXW1929130
  • Passcode: 5640600

To view the slide presentation during the webinar:
https://www.mymeetings.com/nc/join.php?i=PWXW1929130&p=5640600&t=c

Following the webinar, a transcript, recording, and slides will be posted below.

We appreciate your feedback on our webinar program. Following the webinar, we will provide a link to a short survey about the webinar experience.  The survey should take no more than 5-10 minutes to complete. Your responses are confidential and will be used to help ensure the quality of our webinar program.

Note: The FDA does not provide Continuing Education Credits (CEU) or Certificates of Attendance for webinar attendance.

Target Audiences: Industry (medical device companies or distributors, technology manufacturers (including start-up companies or labs), academic and research institutions, healthcare facilities, professional societies, foundations and other non-profits

If you have any questions about this guidance document, please contact CDRH's Division of Industry and Consumer Education (DICE) at dice@fda.hhs.gov, 1-800-638-2041, or 301-796-7100.

Food and Drug Administration
Center for Devices and Radiological Health

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