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

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.

Out-of-office email responses may be the most some in industry can expect from FDA during the ongoing partial government shutdown.

In particular, new PMA and 510(k) submissions, and anything else tied to a user fee payment, are not being reviewed by FDA as of Oct. 1 as a result of...

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