Question: 2 A 510(k) classification refers to a device that requires: A. A full scale audit of the manufacturers production plant every seven years B. Notification

2 A 510(k) classification refers to a device that requires: A. A full scale audit of the manufacturers production plant every seven years B. Notification to FDA before it can be sold on the market C. The manufacturers to submit an application within 3 years of the development of the predicate device. D. FDA to put consider the product under its special program for expedited reviews

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