Summary: On Wednesday, October 2, 2019, the FDA will host a webinar to discuss and answer questions from industry about preparing premarket submissions for dental devices.
Background: A manufacturer who intends to market a dental device should conform to the regulatory controls in the Federal Food, Drug, and Cosmetic Act and the premarket notifications requirements described in Title 21-Code of Federal Regulations. During this webinar, the FDA will:
- Clarify the premarket submissions process, including what to submit and who to work with in the Center for Devices and Radiological Health’s Office of Product Evaluation and Quality (OPEQ)
- Explain information to include in a 510(k) submission in order to avoid refuse-to-accept (RTA) designation
- Clarify medical device reporting (MDR) requirements, including how to report and who should report (manufacturer, dentist, etc.)
- Discuss and answer questions from webinar participants about the premarket submissions for dental devices
Webinar Details:
Registration is not necessary.
Date: October 2, 2019
Time: 01:00 PM – 02:30 PM, EDT
To ensure you are connected, please dial-in 15 minutes prior to the start of the webinar.
U.S. Callers Dial:
- 888-323-9729
- Conference Number: PWXW9364565
- Passcode: 5890890
International Callers Dial:
- 1-212-547-0304
- Conference Number: PWXW9364565
- Passcode: 5890890
To view the slide presentation during the webinar: https://www.mymeetings.com/nc/join.php?i=PWXW9364565&p=5890890&t=cExternal Link Disclaimer
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 (dental device companies or distributors, 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 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.