U.S. flag An official website of the United States government
  1. Home
  2. Medical Devices
  3. News & Events (Medical Devices)
  4. Workshops & Conferences (Medical Devices)
  5. Webinar - Safety and Performance Based Pathway Performance Criteria - 11/07/2019 - 11/07/2019
  1. Workshops & Conferences (Medical Devices)

Webcast

Event Title
Webinar - Safety and Performance Based Pathway Performance Criteria
November 07, 2019


Date:
November 07, 2019
Time:
01:00 PM - 02:30 PM EST
Organized By:
Organizer

Summary: On Thursday, November 7, 2019, the U.S. Food and Drug Administration (FDA) will host a webinar on the Safety and Performance Based Pathway guidances.

Background: On September 19, 2019, the FDA issued four draft guidances and updated a final guidance related to the Safety and Performance Based Pathway as part of our commitment to strengthening and modernizing the 510(k) program, as described in the FDA's Medical Device Safety Action Plan.

As a first step towards operationalizing the Safety and Performance Based Pathway, the FDA issued four draft guidances that identify performance criteria and testing methodologies for certain devices within four class II device types:

The FDA also updated the Safety and Performance Based Pathway final guidance.

Webinar Details:

Registration is not necessary.

Date:  November 7, 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: 

  • 888-945-5893
  • Conference Number:  PWXW9528798
  • Passcode: 5705130

International Callers Dial:

  • 1-212-547-0152
  • Conference Number:  PWXW9528798
  • Passcode: 5705130

To view the slide presentation during the webinar:
https://www.mymeetings.com/nc/join.php?i=PWXW9528798&p=5705130&t=c

Following the webinar a transcript, recording and slides will be available at:
http://www.fda.gov/CDRHWebinar

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 (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 regarding 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

Add this to my Calendar
Outlook users: Click link, select Open, then click Save & Close