Zdrowie i gospodarka · 21.01.1998

Medical Devices; Exemptions From Premarket Notification; Class II Devices

The Food and Drug Administration (FDA) is publishing a list of class II (special controls) devices, subject to certain limitations, that are now exempt from the premarket notification requirements under the Food and Drug Administration Modernization Act of 1997 (the FDAMA). FDA believes that these exemptions will relieve manufacturers from the need to submit premarket notification submissions for these devices and will enable FDA to redirect the resources that would be spent on reviewing such submissions to more significant public health issues. FDA is taking this action in order to meet a requirement of the FDAMA.