Reminder: FDA Webinar – Acceptance Review for De Novo Classification Requests: Final Guidance

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.” 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.

Webinar Details Questions? If you have 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 or DICE@fda.hhs.gov.