FDA Issues Final Guidance on Acceptance Review for De Novo Classification Requests

Today the U.S. Food and Drug Administration (FDA) issued this final guidance, Acceptance Review for De Novo Classification Requests. This guidance  provides clarity about the De Novo pathway and explains the procedures and criteria the FDA will use to determine 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. This guidance fulfills the FDA’s Medical Device User Fee Amendments of 2017 (MDUFA IV) commitment. We recognize and anticipate that both FDA and industry may need up to 60 days to operationalize the policies within the guidance.

Read the Guidance In addition to issuing this final guidance, the FDA revised the following final guidances to include information on the acceptance review of De Novo classification requests: User Fees and Refunds for De Novo Classification Requests FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review Clock and Goals Upcoming webinar on this guidance  The FDA will hold a webinar on Wednesday, September 18, 2019, to discuss and answer questions about this final guidance.