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Medical Devices / Regulatory Affairs

FDA Expands Excepted Device Activities During Government Shutdown

Jan. 15, 2019

The FDA has expanded its scope of excepted work to include inspection activities that go beyond “for-cause” inspections, such as surveillance inspections of the highest-risk device products and facilities, FDA Commissioner Scott Gottlieb tweeted.

Additional activities related to medical devices will be considered excepted, unpaid agency work as long as the government remains closed, he said.

The FDA is also expanding its monitoring and evaluations of medical device adverse events and malfunctions to include more types of devices.

“FDA is working to operationalize additional activities that exceed what we’ve done in past shutdown situations,” Gottlieb said.

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