Wednesday 24 January 2018

FDA/USDA Shutdown Ending, Expect Lengthy Delays

The government shutdown that shuttered the doors of the USDA and FDA has ended. The Agencies are expected to return back to normal operations on Thursday. For a few weeks, however, nothing will be normal about the Agencies. The nearly three week long shutdown will continue to impact industry even with the Agencies now open. There is a back-log of unprocessed requests, such as establishment registration fees, pre-market approval submissions (NDAs, 510(k)s), and other outstanding requests, like detention orders and advisory meetings. Add to this three weeks of missed correspondence and it becomes clear the impact remains. While the government was shutdown industry was still at work. Delays should be expected for at least the first month after the shutdown.

The biggest impact may be on medical devices. The US is already seen as much slower in approving most devices. This reputation will only be exacerbated as the Center for Devices and Radiological Health (CDRH) copes with the three week shutdown. During the shutdown the CDRH was prevented from any review of pre-market submission submitted after Oct. 1 and was limited on what activities it could complete with user fees from FY 2013. For startups in the industry added delays could make seeking approval in Europe or Latin America more tempting.

Enforcement actions will be hampered by delays. As regional offices come back online there will be a deluge of activities. Close outs of existing warning letters, recalls and 483s could be pushed out by several weeks. Responses to enforcement actions issued before the shutdown will likely be slow coming. It’s possible in the rush to catch-up in the run up to the holidays compliance issues are overlooked. This could add to delays as reinspections conducted as part of the close out find the overlooked issues.

The full impact remains to be seen, but expect delays and an adjustment period before it’s business as usual.

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