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Shutdown Realities At FDA: No New Submission Reviews, And More

This article was originally published in The Gray Sheet

Executive Summary

New PMA and 510(k) submissions, and anything else tied to an FY 2014 user fee payment, are not being reviewed by FDA as of Oct. 1. The limited carryover-FY 2013 user fees FDA has are supporting ongoing reviews, while the registration and listing and export certification database entry systems are unavailable.

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