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

The Food and Drug Administration (FDA) is reclassifying 111 generic types of class II devices into class I based on new information respecting such devices. FDA is also exempting the 111 generic types of devices, and 11 already classified 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. These devices will remain subject to current good manufacturing practice (CGMP) regulations and other general controls. This rulemaking is part of the President's and Vice President's Reinventing Government effort.