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

Article preview from "The Gray Sheet" - October 7, 2013

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.
 

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

Article preview from "The Gray Sheet" - October 7, 2013

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 the impasse in Congress on funding government agencies for the start of fiscal year 2014.

FDA said it does not have legal authority to accept user fees assessed for fiscal year 2014 until an appropriation for the year is enacted. “This means that until operations resume, FDA will NOT collect any 2014 user fees and will NOT be able to accept any new regulatory submissions that require a fee payment,” the agency stated on its website.

In practice, at least for 510(k)s, the agency is physically accepting the submissions, but will not review them until after the shutdown is over, according to Jeffrey K. Shapiro, an attorney with Hyman, Phelps & McNamara P.C., basing his comments on an Oct. 3 conversation with 510(k) policy staff at CDRH.

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