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Home » FDA Updates 510(k) Refuse-to-Accept Policy, Aim is to Speed Process
FDA Updates 510(k) Refuse-to-Accept Policy, Aim is to Speed Process
August 17, 2012
The 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.