The Food and Drug Administration (FDA) recently identified a list of Class II Medical Devices that, when finalized, will be exempt from premarket notification (510(k)) requirements. This publication was made by the FDA pursuant to the 21st Century Cures Act, signed into law on December 13, 2016.
Premarket notification (510(k)) is one of several alternative procedures that medical device manufacturers must undergo before being able to market their medical devices intended for human use. The 510(k) notification is required for medical devices that do not need to receive premarket approval (PMA) from the FDA and are not exempt from the 510(k) requirement. The FDA explains that medical devices are classified into three classes (Classes I, II, and III) based on based on the level of control necessary to assure the safety and effectiveness of the device. Most Class I and II devices and a few Class III are subject to the 510(k) requirement. Although a 510(k) applicant does not need to provide scientific evidence of safety and effectiveness for the intended use of its device, the applicant must demonstrate that the device is at least as safe and effective (“substantially equivalent”) to a legally marketed device (“predicate device”).
The FDA may exempt devices from 510(k) requirement. A list of factors that the FDA use to determine whether the device is exempt from 510(k) requirements includes: (1) whether the device does not have a significant history of false or misleading claims or of risks associated with inherent characteristics of the device; (2) whether characteristics of the device necessary for its safe and effective performance are well established; (3) whether changes in the device that could affect safety and effectiveness will either (a) be readily detectable by users by visual examination or other means before causing harm or (b) not materially increase the risk of injury, incorrect diagnosis, or ineffective treatment; and (4) any changes to the device would not likely to result in the device’s classification.
Section 3054 of the 21st Century Cures Act amended sections 510(l) and 510(m) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The amended sections 510(l) and 510(m) of the FD&C Act require the FDA to publish any Class I and Class II devices that the FDA determines no longer require premarket notifications under section 510(k) of the FD&C Act to provide reasonable assurance of safety and effectiveness. The FDA is required to publish initial lists for Class II devices and Class I devices within 90 days and 120 days, respectively, after the enactment of the 21st Century Cures Act and then to update the lists at least once every 5 years.
A list of 510(k)-exempt Class I devices is expected to be published in about 30 days.