The US Food and Drug Administration (“FDA”) recently released updated recommendations to exempt certain unclassified, Class I, and Class II medical devices from premarket notification requirements. The devices include certain anesthesiology, cardiovascular, general and plastic surgical, and neurological devices. “The FDA believes devices identified in . . . this guidance document are sufficiently well understood and do not require premarket notification (510(k)) to assure their safety and effectiveness.” Until a final rule on the issue is published, the FDA has announced that it does not plan to enforce compliance with 510(k) requirements for devices in the listed categories and does not expect manufacturers to submit 510(k) submissions for these devices.
The FDA explains that section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. Such Premarket Notification (also known as PMN and 510(k)) allows the FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. Thus, “new” devices (defined as “not in commercial distribution prior to May 28, 1976”) that have not been classified can be properly identified. Specifically, medical device manufacturers are required to submit a 510(k) if they intend to introduce a device into commercial distribution for the first time or reintroduce a device that will be significantly changed or modified to the extent that its safety or effectiveness could be affected.
The FDA’s recommendation comes after the FDA drafted a commitment letter in 2012 in which it agreed to identify low-risk medical devices to exempt from 510(k) requirements. The recommendations are open to public comment online.
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