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Home » 510(k), PMA Acceptance Guidelines Finalized as of First of Year
510(k), PMA Acceptance Guidelines Finalized as of First of Year
January 4, 2013
FDA reviewers evaluating completeness of 510(k) submissions should consider only the presence of required information, and not whether it appears to be adequate, according to a final guidance on the agency’s 510(k) refuse-to-accept policy.