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Summary: On Wednesday, September 18, 2019, the U.S. Food and Drug Administration (FDA) will host a webinar to discuss and answer questions about the final guidance entitled, "Acceptance Review for De Novo Classification Requests."

Background: This final guidance fulfills the FDA's Medical Device User Fee Amendments (MDUFA IV) commitment to provide clarity about the De Novo pathway and explains the procedures and criteria the FDA intends to use in determining if a submitted De Novo classification request (De Novo request) meets a minimum threshold of acceptability and should be accepted for substantive review. This guidance also includes a De Novo Acceptance Checklist and a Recommended Content Checklist to help device manufacturers.

Providing clarity on the FDA's expectation for information to be submitted in a De Novo request will help ensure predictability and consistency for industry when preparing submissions and will enhance patient access to new, safe, and effective medical devices.

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 [email protected], 1-800-638-2041, or 301-796-7100.

Food and Drug Administration
Center for Devices and Radiological Health