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The 510(k) procedure is a North American regulatory provision allowing market access for all Class I, II and III medical devices (North American classification) for which the applicant is able to demonstrate substantial equivalence with devices already marketed ("predicate devices") in North America. The structure of the 510(k) file is relatively well defined in North American regulations, enabling the applicant to build an acceptable product file. However, this 510(k) procedure presupposes a prerequisite often neglected (not to say concealed) by applicants: the concealment of this prerequisite results in part from the partial absence of control by the Food and Drug Administration (FDA) and relies on a commitment from the applicant.

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