FDA Exempts 1,003 Class II Devices From 510(k) Regs
The FDA has finalized its list of 1,003 class II medical devices low-risk enough to be exempt from 510(k) requirements.
The list is part of a 21st Century Cures Act provision that aims to reduce devicemakers’ regulatory burden. The device types on the list were deemed a sufficiently low-risk not to require a premarket notification review to determine safety and effectiveness.
The agency noted, however, that the devices on the list are not exempt from other regulations or requirements unless that exemption is specifically established by another law or order. All devices, exempt and otherwise, are subject to current device GMPs, packaging and labeling rules, and regulations on intended use.