The U.S. Food and Drug Administration (FDA) regulates medical devices in the U.S. The FDA keeps extensive databases on these devices containing lists of the devices, their safety records, pre-market notifications, and pre-market approval notices, to name a few.
Section 510(k) of the Food, Drug and Cosmetic Act requires regulated medical device manufacturers to notify the FDA at least 90 days in advance of their intent to market a medical device. This is known as Premarket Notification — also called PMN or 510(k). It allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories.
This allows “new” (unclassified) devices (those not in commercial distribution prior to May 28, 1976) to be properly identified. Specifically, medical device manufacturers are required to submit a premarket notification if they intend to introduce a device into commercial distribution for the first time.
The 501(k) notification must also be submitted when reintroducing a device that has been significantly changed or modified to the extent that its safety or effectiveness could be affected. These...
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