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FDA Updates 510(k) Refuse-to-Accept Policy, Aim is to Speed Process
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. The draft guidance, released Aug. 13, is intended to prevent requests for additional information and lengthy review times that resulted from earlier guidance, which focused on policy and administrative considerations at the expense of specific advice.
Devices & Diagnostics Letter |
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