510(k) Premarket Clearance Requirements for Medical Devices

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When a manufacturer wishes to introduce a new medical device or reintroduce a device that will be significantly changed or modified to the extent that its safety or effectiveness could be affected, the manufacturer must provide the U.S. Food and Drug Administration (FDA) with a Premarket Notification (PMA) in the form of a 510(k) submission at least 90 days in advance of commercial distribution so that the FDA can determine if the device is “substantially equivalent” to a device already placed in one of the FDA’s three classification categories. After the 510(k) has been submitted, the manufacturer must receive premarket clearance from the FDA before the device can be commercially distributed.

The requirement that a new device be substantially equivalent to a device that is already legally in commercial distribution is designed to ensure that the new device is at least as safe and effective as the predicate device. A device will be considered substantially equivalent if (1) it has the same intended use as the predicate device and the same technological characteristics as the predicate; or (2) it has the same intended use as the predicate and, if it has different technological characteristics, the information provided to the FDA does not raise new questions of safety and effectiveness and demonstrates that the device is at least as safe and effective as the legally marketed device. The devices do not need to be identical to be considered substantially equivalent.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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