US Government Shutdown Would Hamper FDA Clearance and Approval Process

A potential shutdown of the US government due to Republican lawmakers’ stance on budget negotiations would significantly reduce the Food and Drug Administration’s ability to conduct inspections of food, pharmaceutical products and medical devices.

A report by CNN cited an unnamed FDA official, who said that although some FDA inspectors will remain on staff if a shutdown does occur, the agency’s divisions including the Center for Devices and Radiological Health will not be able to function at full capacity.

The agency would prioritize inspection sites according to risk; inspectors would focus primarily on manufacturing facilities historically categorized as high-risk, with less time devoted to routine plant inspections. The FDA would not have the resources, however, to carry out inspections of medical device or pharmaceutical manufacturing facilities as part of new product applications.

A shutdown would constitute an expensive, ill-timed and wholly unnecessary roadblock for device manufacturers currently involved in clearance and approval processes. Congressional negotiators do not have much time to pull back from the brink.

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