FDA Shutdown

FDA Shutdown

The partial government shutdown, now in its 24th day with impacts at the FDA felt across all its Centers.

Currently, with the FDA shutdown, most if not all functions are limited to safety inspections. In a series of tweets on Sunday, FDA Commissioner Scott Gottlieb, M.D. stated the shutdown, “represents one of the most significant operational challenges in FDA’s recent history.” He went on to list the tasks that the agency has added to “excepted, unpaid work”, all of which related to surveillance and inspections to protect public health.

Those activities include:

  • Expanded inspection activities beyond “for-cause” inspections to also include foreign and domestic food, drug, medical, device and pharmacy compounding surveillance inspections focused on the highest-risk products and facilities.
  • Surveillance sampling of imported high-risk foods, drugs, and devices, and logistical coordination and laboratory support for allowable inspections and evaluation.
  • Expanded monitoring and evaluating medical device adverse event and malfunction reports to include additional types of medical devices.
  • Expanded activities related to surveillance and response for recalls (including Class I and Class II) as necessary to identify and respond to threats to the safety of human life.

The pre-market side has nearly ground to a halt. New device and drug submissions, like 510(k)s, are not currently being accepted. This includes pre-submissions intended to gain feedback on a pending submission. Even simple requests, like filing for a NDC relabeler code or a VCRP 2511 or 2512 cosmetic listing are paused or delayed. Even where there is an existing userfee to cover work, response times are delayed as it appears reviewers work fewer hours.

The FDA shutdown will be most strongly felt on the pre-market side where a back-log of work is building. With no end in sight, the impacts of this shutdown will only grow worse.

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Marc is dedicated to helping his clients navigate the complex world of FDA and USDA legislation. He represents FDA-regulated companies in the food, dietary supplement, beverage, cosmetic, medical device, and drug industries.

Marc is the author of two textbooks and a lecturer at Northeastern University. He is a member of the Washington State Bar Association and the D.C. Bar Association.

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