FDA Only Half Closed For Business

Wednesday, October 09, 2013

While the nation scrambles to make heads or tails out of the dumb-founding decision by Congress to operate the US government with no budget, FDA has helpfully posted the following modest notice titled: For Industry – Medical Product Activities During the Federal Government Shutdown. 

The goal of this document is to summarize the anticipated scope of FDA activities beginning on October 1, 2013 and continuing until the madness ends or gets worse, the unfortunately imaginable event in which Congress leads the charge over the cliff to budgetary default.

The overview to the FDA notice is nothing if not prudent indicating that activities related to medical products generally will be limited:

  • To work involving the safety of human life or to the protection of property and
  • To activities funded by carryover user fee balances.

The latter, while at first blush seems to provide FDA with an out from the general government shut-down, is actually quite constrained. FDA does not have legal authority to accept user fees for the fiscal year 2014 (which began on October 1, 2013) until either a 2014 appropriation is passed or a Continuing Resolution for FDA is enacted. As a result 45% of its work force (some 6600 employees) are on furlough, being paid (albeit belatedly) to stay at home and not work.

October 1, 2013 becomes the bewitching hour. CDRH will continued to work on submissions received prior to this date (whether fee based or not). FDA will not accept new regulatory submissions after that date that require fee payment. The agency can paradoxically continue to accept and review new submissions for which no fee is required.

As a result while FDA finishes up old business (submissions in the queue as of September 30, 2013 to include advisory panels when necessary), beginning on October 1, 2013 it is no longer in business for the following modest list of new submissions:

  • Premarket approvals (PMAs)
  • Product Development protocols (PDPS)
  • Premarket Reports (PMRs)
  • Original BLS and BLA efficacy supplements for medical devices reviewed by CBER
  • Some PMA and PDP supplements
  • 510(k)s
  • 513(g)s
  • Annual reports

For those seeking solace in the ability to continue to benefit from FDA work on submissions already in the pipeline or on new non-fee paying submissions such as Investigational Device Exemptions (IDES), De novos, pre-submissions and others, a word of caution is in order. FDA repeatedly notes “the Agency may suspend work on certain submission types during the lapse period due to resource constraints.” It is hard to know what that means but it is easy to guess this may not be business as usual.

And to those worried about the opportunity cost of lost time in bringing medical products to market, there is one final reality check to the madness here, not reflected in this FDA memo. The acronym FDA starts with food not medical products. Thanks to the furlough, the 80% of US food (especially imports) regularly inspected by FDA food safety inspectors is now headed to your local grocer unimpeded by this regulatory nicety. While pondering what to do with your latest FDA submission you may also want to consider not eating until the shutdown is over

Tags: 510(k), CDRH, FDA, Industry, Obama Administration, PMA, Policy, Politics

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