Regulacje i polityka gospodarcza · 24.12.1996

Medical Devices; Reclassification and Exemption From Premarket Notification for Certain Classified Devices

The Food and Drug Administration (FDA) is reclassifying scented or scented deodorized menstrual pads from class II into class I based on new information respecting such device. FDA is also exempting this device, and one already classified generic type of class I device, unscented menstrual pads, from the requirement of premarket notification, with limitations. FDA has determined that manufacturers' submissions of premarket notifications for these devices 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. These exemptions allow the agency to make better use of its resources and thus better serve the public.