Summary 

On Tuesday, December 14, 2021, at 1:00 pm ET, the U.S. Food and Drug Administration (FDA), hosted a webinar for stakeholders interested in learning about the final rule, Medical Device De Novo Classification Process, and associated guidance document updates. 

This webinar:     

• Described the background and history of the De Novo Program
• Described the new De Novo regulations and changes to the De Novo review process
• Described what the updated De Novo guidance documents cover
• Identified the contents of the updated De Novo Refuse-to-Accept (RTA) checklist and what is required for acceptance of a De Novo request

We encouraged all interested stakeholders to join. 

Background 

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

Consistent with the final rule, the FDA updated the guidance documents below to provide recommendations for submitting De Novo requests, as well as criteria and procedures for accepting, withdrawing, reviewing, and making decisions on De Novo requests:

• De Novo Classification Process (Evaluation of Automatic Class III Designation): Guidance for Industry and Food and Drug Administration Staff
• Acceptance Review for De Novo Classification Requests: Guidance for Industry and Food and Drug Administration Staff
• FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review Clock and Goals: Guidance for Industry and Food and Drug Administration Staff
• User Fees and Refunds for De Novo Classification Requests: Guidance for Industry and Food and Drug Administration Staff

Meeting Materials

Presentation, printable slides, and transcript are available at CDRH Learn – How to Study and Market Your Device, sub-section “De Novo”