Article preview from "The Gray Sheet"- August 13, 2012
Draft guidance outlines criteria that 510(k) submissions must meet before the agency begins its substantive review.
A draft guidance 
released Aug. 10, “Refuse to Accept Policy for 510(k)s,” modifies guidances from 1993 and 1994 by adding a quick, early-review process for FDA to determine that a submission contains all the necessary elements and contents of a complete 510(k) package. Within 15 calendar days of receiving the 510(k), FDA will tell the sponsor whether the submission is complete and, if not, which elements are missing.
The guidance comes on the heels of a similar draft guidance for pre-market approval applications intended to quickly identify incomplete PMAs.
FDA explains that the previous refuse-to-accept guidances for 510(k)s focused on administrative elements and broad principles, rather than on the specific content that is essential for 510(k) review.
“As a result, FDA accepts many inadequate submissions for review and FDA staff invests significant time in constructing extensive letters requesting all of the additional information needed to conduct a substantive review,” FDA says in the new draft. “This approach is an inefficient use of resources and frequently lengthens review times.”
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