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International Medical Device Regulatory Monitor
September 2012 | Vol. 20 No. 9
Updates to U.S. 510(k) Refuse-to-Accept Policy Aimed at Speeding Up Process
The U.S. Food and Drug Administration (FDA) has compiled a checklist for agency staff and industry to use in determining whether a 510(k) submission is adequate and ready for review, as part of the agency’s move from a 30-day to a 15-day time-to-acceptance decision.
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