Reminder: Join us on December 14 for a Webinar on Medical Device De Novo Classification Process

The U.S. Food and Drug Administration (FDA) will host a webinar to share information and answer questions about the final rule and new regulations implementing the Medical Device De Novo Classification Process and associated guidance updates.

This final rule describes the FDA's De Novo classification process that provides a pathway for certain novel medical devices to be classified as class I or class II, rather than automatically as a class III device, which requires premarket approval (PMA). A device classified by a De Novo request becomes the first device of its type and may serve as a predicate for future 510(k) premarket submissions, when necessary.

The FDA's De Novo classification process aims to ensure patients have access to safe and effective devices. This final rule provides clarity and transparency about the FDA's expectations and processes for De Novo classification to FDA reviewers, medical device industry, stakeholders, and the public. The final rule is effective January 3, 2022.

• Date: Tuesday, December 14
• Time: 1:00 to 2:00 p.m. ET

Registration: Registration is not required. View webinar details for call-in information.

View Details

During this webinar, the FDA will:

• Describe the background and history of the De Novo Program
• Describe the new De Novo regulations and changes to the De Novo review process
• Describe what the updated De Novo guidance documents cover
• Identify the contents of the updated De Novo Refuse-to-Accept (RTA) checklist and what is required for acceptance of a De Novo request
• Answer your questions about the Medical Device De Novo Classification Process

Questions?

If you have questions about the Medical Device De Novo Classification Process, contact the Division of Industry and Consumer Education.