The FDA release a final guidance, “De Novo Classification Process (Evaluation of Automatic Class III Designation),” on October 30, 2017. This supersedes “New Section 513(f)(2) – Evaluation of Automatic Class III Designation, Guidance for Industry and CDRH Staff” dated February 19, 1998. This guidance defines the process for De Novo submissions for devices with no predicate that previously would automatically have been considered Class III; provided there is not current classification rule for this type of device. This guidance clarifies that a 510(k) with an NSE determination is no longer required for De Novo submission. The guidance recommends but does not require a Pre-Sub review with FDA. The full guidance is at this link: De Novo Guidance.
