FDA Issues Final Rule for De Novo Classification

The U.S. Food and Drug Administration (FDA) issued the final rule on 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 applicable.

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 will become effective 90 days after the date of publication in the Federal Register.

Read the Final Rule

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

The minor updates include the addition of appropriate regulatory references throughout the guidance documents in light of the final rule, and other updates to the guidances to be consistent with the final rule. For example, in updating the Acceptance Review for De Novo Classification Requests guidance to align with the final rule, Appendix B (Recommended Content Checklist for De Novo Classification Requests) of this guidance has been removed and all elements described in the new regulation are included in Appendix A (Acceptance Checklist for De Novo Classification Requests). The revised guidances will supersede the existing final guidances on the effective date of the final rule.

Questions?

If you have questions about this final rule or these guidance documents, contact the Division of Industry and Consumer Education.