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  5. Webinar - The Special 510(k) Program: Final Guidance - 10/31/2019 - 10/31/2019
  1. News & Events (Medical Devices)


Event Title
Webinar - The Special 510(k) Program: Final Guidance
October 31, 2019

October 31, 2019
01:00 PM - 02:30 PM EDT
Organized By:

Summary: On October 31, 2019, the U.S. Food and Drug Administration (FDA) will host a webinar for device manufacturers and industry to discuss and answer questions about the Special 510(k) Program Final Guidance.

Background: On September 12, 2019, the FDA issued a final guidance document on the Special 510(k) Program.

"The New 510(k) Paradigm: Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications" guidance is superseded by this final guidance document and The Abbreviated 510(k) Program, which reflects the Abbreviated 510(k) information from the New 510(k) Paradigm guidance.

The FDA also updated the following final guidance documents to reflect the updated Special 510(k) Program, improve alignment between the related 510(k) guidance, and reflect current policies:

Together, these guidance documents provide consistency, clarity and transparency to industry and the FDA and may conserve resources for both, while still protecting public health, and not altering the statutory criteria for substantial equivalence.

Webinar Details:

Registration is not necessary.

Date: Thursday, October 31, 2019
Time: 1:00 PM - 2:30 PM, EDT
To ensure you are connected, please dial-in 15 minutes prior to the start of the webinar.

U.S. Callers Dial:

  • 888-390-1068
  • Conference Number: PWXW9502204
  • Passcode: 6352340

International Callers Dial:

  • 1-212-547-0152
  • Conference Number: PWXW9502204
  • Passcode: 6352340

To view the slide presentation during the webinar: https://www.mymeetings.com/nc/join.php?i=PWXW9502204&p=6352340&t=c

Following the webinar, a transcript, recording and slides will be available at:

We appreciate your feedback on our webinar program. Following the webinar, we will provide a link to a short survey about your FDA CDRH webinar experience, which 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, third party review organizations, technology manufacturers (including start-up companies or labs), academic and research institutions, health care facilities, professional societies, foundations and other non-profits.

If you have any questions regarding this final 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.

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