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.
Under section 513 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360c), FDA must classify devices into one of three regulatory classes: Class I, class II, or class III. FDA classification of a device is determined by the amount of regulation necessary to provide a reasonable assurance of safety and effectiveness. Under the Medical Device Amendments of 1976 (1976 amendments) (Pub. L. 94-295), and the amendments of the Safe Medical Devices Act of 1990 (Pub. L. 101-629), devices are to be classified into class I (general controls) if there is information showing that the general controls of the FD&C Act are sufficient to assure safety and effectiveness; into class II (special controls), if general controls, by themselves, are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls to provide such assurance; and into class III (premarket approval), if there is insufficient information to support classifying a device into class I or class II and the device is a life sustaining or life supporting device or is for a use which is of substantial importance in preventing impairment of human health or presents a potential unreasonable risk of illness or injury.
More information is available via the Federal Register notice.