- October 2, 2019
- Organized By:
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