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A company that wants to market a medical device in the US, for which a Premarket Approval (PMA) is not required, must submit a 510(k) to FDA unless the device is exempt from 510(k) requirements. Before marketing a device, each submitter must receive an order from FDA which finds the device to be substantially equivalent (SE) and states that the device can be marketed in the US. This order “clears” the device for commercial distribution. A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (predicate device) that is not subject to PMA.
PMA is the most stringent type of device marketing application required by FDA. The applicant must receive FDA approval of its PMA application prior to marketing the device. PMA approval is based on a determination by FDA that the PMA contains sufficient valid scientific evidence to assure that the device is safe and effective for its intended use(s).
The De Novo request provides a marketing pathway to classify novel medical devices for which general controls, or general and special controls, provide reasonable assurance of safety and effectiveness for the intended use but for which there is no legally marketed predicate device. De Novo classification is a risk-based classification process. Devices that are classified into class I or class II through a De Novo classification request (De Novo request) may be marketed and used as predicates for future premarket notification [510(k)] submissions, when applicable.
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