Reminder - Webinar: Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics: Final Guidance – November 1, 2019

Webinar: Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics: Final Guidance – November 1, 2019

REMINDER On September 24, 2018, the FDA released a final guidance about the factors the FDA considers when evaluating benefits and risks of a new device compared to a predicate device during a Premarket Notification 510(k) review when the FDA has determined that the intended use of the device is the same, but there are different technological characteristics. The recommendations in the final guidance do not change the 510(k)-premarket review standard or require 510(k) submitters to provide additional performance data beyond what would normally be requested during the review process. On Thursday November 1, 2018, the FDA will host a webinar for device manufacturers and industry to discuss and answer questions about this final guidance. Webinar Details: No registration is required. Date: Thursday November 1, 2018 Time: 3:00 – 4:30 PM Eastern Standard Time To ensure you are connected, please dial-in 15 minutes prior to the start of the webinar NOTE: You must dial-in to hear the presentation and ask questions: U.S. Callers Dial: 1-888-603-9710 Conference Number: PWXW8123985; Passcode: 6415981 International Callers Dial: 1-630-395-0439 Conference Number: PWXW8123985; Passcode: 6415981 To view the slide presentation during the webinar: https://www.mymeetings.com/nc/join.php?i=PWXW8123985&p=6415981&t=c Following the webinar, a transcript, audio 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. Target Audience: Industry If you have any questions, please contact the Division of Industry and Consumer Education (DICE) in the Center for Devices and Radiological Health (CDRH) at 1-800-638-2014, 301-796-7100 ordice@fda.hhs.gov