FDA Proposed Rule: Medical Device De Novo Classification Process

This proposed rule was issued on December 4, 2018, by the U.S. Food and Drug Administration (FDA). The provisions are intended to modernize the FDA device approval pathway for low-to-moderate risk devices and technologies that have no predicate device to use in determination of substantial equivalence. The De Novo pathway provides a vehicle for establishing new predicate devices that can reflect modern standards for performance and safety and can serve as the basis for future clearances. The proposed rule would, if finalized, will facilitate appropriate classification of new types of medical devices . . .