USA – FDA finalizes long delayed de novo classification rule

The US Food and Drug Administration (FDA) on Monday issued a final rule setting requirements for the medical device de novo classification process, codifying procedures and criteria for new types of medical devices to be authorized as Class I or Class II devices.

« These requirements are intended to ensure the most appropriate classification of devices consistent with the protection of the public health and the statutory scheme for device regulation. They are also intended to limit the unnecessary expenditure of FDA and industry recourses that may occur if devices for which general controls and special controls provide a reasonable assurance of safety and effectiveness are subject to premarket approval, » FDA explains. The final rule will take effect in 90 days.

The final rule comes three years after FDA first proposed it, and its issuance has been on the agency’s to-do list to finalize for the last two years. (RELATED: FDA proposes rule to implement new de novo classification processRegulatory Focus 4 December 2018; Unified Agenda: A look at FDA’s upcoming rulemakingRegulatory Focus 17 June 2021)…