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510(K) Medical Device Exemptions

FDA announced this week a list of more than 1,000 medical devices that will now be exempt from 510(k) notification requirements — a move that aims to help speed up the process of bringing new medical devices to market. The decision was made this week in accordance with a process laid out by the 21st Century Cures Act, a law passed by Congress in 2016 to provide funding for the research and development of new drugs and medical devices.

Some of the notable devices included on the list are umbilical clamps, menstrual cups, dentures, acupuncture needles, surgical lights, and obstetrical forceps, among a bevy of other devices.

A 510(k) is a premarket submission made to FDA to obtain marketing clearance for a device by demonstrating that the device is “substantially equivalent” in safety and effectiveness to another lawfully marketed device. The 21st Century Cures Act now requires FDA to determine which class II devices no longer require this premarket clearance, and according to the FDA notice, the new list of exemptions aims to help the medical device industry by eliminating costs and expediting the process of compliance.

The FDA notice also notes that these new exemptions will decrease regulatory burdens on the medical device industry, while eliminating many of the private costs and expenditures that are often required to comply with the federal regulation. The move is also expected to decrease FDA’s workload with an immediate reduction in the number of devices awaiting evaluation.

However, the decision doesn’t come without risk. There has been a growing voice of concern from members of the medical device community who fear that a number of these moderate-risk devices could still pose a risk to not only patients but the doctors that prescribe them. There is also a fear that the decision could result in less information about the devices being made available to the public, specifically with regard to the safety and effectiveness of each device.

FDA maintains that the manufacturers of these devices still have extensive responsibilities to ensure that their devices and diagnostics comply with regulatory requirements, including quality system and medical device reporting requirements.