Manufacturers can show that a device to be marketed is substantially equivalent to a marketed product that was on the market prior to 28 may 1976, by submitting a Premarket Notification.
Device manufacturers who are required to register are required by Section 510(k) of the Food, Drug and Cosmetic Act to give FDA at least 90 days' notice of their intention to commercialize a medical device.
Premarket Notification, often known as PMN or 510, is what this is (k). This enables FDA to decide whether the device is comparable to a device that has already been classified into one of the three categories.
Thus, "new" devices that weren't classified and weren't in commercial distribution before May 28, 1976, can be appropriately identified.
Manufacturers of medical devices must file a premarket notification, specifically, if they plan to release a new device into commercial distribution or rerelease an older product with significant changes.
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