The purpose of this document is to explain the procedures and criteria FDA intends to use in assessing whether a request for an evaluation of automatic class III designation (De Novo classification request or De Novo request) meets a minimum threshold of acceptability and should be accepted for substantive review.
The information presented in this document is intended to provide De Novo requesters with transparency regarding the types of information FDA believes are necessary to conduct a substantive review for a De Novo request.
This document includes both an Acceptance Checklist (Appendix A. Acceptance Checklist for De Novo Classification Requests) as well as a Recommended Content Checklist (Appendix B. Recommended Content Checklist for De Novo Classification Requests)