Medical Devices; Exemptions From Premarket Notification for Class I and Class II Devices
«The Food and Drug Administration (FDA, Agency) identified a list of class I devices and class II devices that are now exempt from premarket notification requirements, subject to certain limitations. FDA published the lists of final determinations in accordance with procedures established by the 21stCentury Cures Act (Cures Act). Although each classification regulation for each such type of device shall be deemed amended to incorporate such exemption.»
