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In effect, the De Novo process is primarily a regulatory pathway for: (1) adding categories of medical devices, and their associated new product codes and regulatory numbers to the CFR, (2) classifying the devices in these new categories according to their risk as either class I (low risk devices requiring general controls) or class II (moderate risk devices also requiring special controls), (3) establishing the first predicate device for the new product code (device category), and (4) enriching the 510(k) pathway by enabling follow on devices (with the same intended use and general technological characteristics) to use the 510(k) regulatory pathway for market clearance

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10.1016/j.jff.2016.06.032 J