On October 3, 2011, the FDA released draft guidance entitled “De Novo Classification Process (Evaluation of Automatic Class III Designation).” The document is intended to provide guidance to FDA staff and industry on the process for the submission and review of petitions submitted under the Federal Food, Drug, and Cosmetic Act, also known as the de novo classification process. The draft guidance contains updated recommendations designed to foster efficient interaction with FDA, including what information to submit, when seeking a path to market via the de novo process. It also describes a mechanism to provide greater clarity about the suitability of a device for de novo review, and timely input on the type of data necessary to support de novo classification of an eligible device. Comments on the guidance should be submitted by December 2, 2011.