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In contrast to the PMA approval process, FDA requires that a product marketed via the 510(k) process demonstrate substantial equivalence to a predicate device or devices. A predicate device is a legally U.S. marketed device not subject to a PMA. For a new device to be deemed SE, it must be at least as safe and effective as the predicate. Call : 08133332950 Visit : https://biotechresearchgroup.com/fda-services/510k-consultants/
