De Novo Classification Process (Evaluation of Automatic Class III Designation); Guidance for Industry and Food and Drug Administration Staff; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``De Novo Classification Process (Evaluation of Automatic Class III Designation).'' The purpose of this document is to provide guidance on the process for the submission and review of a De Novo classification request (hereafter a ``De Novo request'') under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), also known as the De Novo classification process. FDA is issuing this guidance to also provide updated recommendations for interactions with FDA related to the De Novo classification process, including what information to submit when seeking a path to market via the De Novo classification process. This guidance replaces ``New Section 513(f)(2)--Evaluation of Automatic Class III Designation, Guidance for Industry and CDRH Staff,'' dated February 19, 1998.