Medical Devices; Exemptions From Premarket Notification: Class II Devices; Request for Comments

The Food and Drug Administration (FDA or Agency) has identified a list of class II devices that, when finalized, will be exempt from premarket notification requirements, subject to certain limitations. FDA is publishing this notice of that determination and requesting public comment in accordance with procedures established by the 21st Century Cures Act. This notice does not represent FDA's final determination with respect to the class II devices included in this document. FDA will review any comments submitted within the 60-day comment period and will consider whether the list of class II devices should be modified prior to publication of its final determination in the Federal Register.