Simplifying Global Compliance
U.S. FDA Issues Final Guidances on 510(k) Refuse-to-Accept, PMA Review Policies
International Medical Device Regulatory Monitor
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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