The FDA plans to apply exemptions from the requirement of 510(k) Premarket Notification to specific unclassified medical devices and some Class I and II devices. Its Guidance of August 14, 2015, lists the medical devices in question and announces their exemption from the requirement for 510(k) clearance with immediate effect. A final formal regulation is to follow.
510(k) exemption applies with immediate effect to these devices
Section IV of the FDA’s Guidance dated August 14, 2015, lists all devices that are regarded as adequately understood and thus as safe and effective. These include anesthesiology, cardiovascular, dental medical, ENT, gastroenterology, urology, surgical, neurological, obstetrical, gynecological ,and ophthalmological medical devices as well as medical devices for general hospital use, for personal use and for use, in physical medicine.
After incorporation of objections, the scope of the original Guidance from July 1 was expanded to add a further eight devices, bringing the total covered to 128 as given in the update of August 14. The FDA emphasizes that exemptions from 510(k) clearance does not exempt manufacturers from compliance with all other requirements in areas such as registration, labeling, good manufacturing practices, and reporting of incidents.