The Food and Drug Administration (FDA) has issued draft industry and staff guidance pertaining to its de novo classification process, which “provides a route to market for medical devices that are low to moderate risk, but that have been classified in class III because FDA has found them to be ‘not substantially equivalent’ (NSE) to legally marketed predicate devices.” The guidance, distributed for public comment only, explains when the process may be used, how de novo information and the de novo petition should be submitted, and the process that staff will use to review these petitions. While comments on the guidance may be submitted at any time, they are requested by December 2, 2011, for consideration in FDA’s preparation of the final guidance document. See Federal Register, October 3, 2011.