U.S. FDA Issues Final Guidances on 510(k) Refuse-to-Accept, PMA Review Policies

International Medical Device Regulatory Monitor
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U.S. Food and Drug Administration (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.

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