21 CFR Parts 864, 866, 868, 870, 872, 874, 876, 878, 880, 882, 886, 888, 890, and 892

Resumo

The Food and Drug Administration (FDA) is exempting 148 generic types of class I devices from the requirement of premarket notification, with limitations. For the exempted devices, FDA has determined that manufacturers' submissions of premarket notifications are unnecessary for the protection of the public health and that the agency's review of such submissions will not advance its public health mission. The exemptions allow the agency to make better use of its resources and thus better serve the public.