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FDA’s Shuren On Why Agency Broke Up Its IVD And Radiological Health Office

 
• By Shawn M. Schmitt

The US FDA split its Office of In Vitro Diagnostics and Radiological Health in two earlier this week because it “really had two flavors of technology – actually three – that sat in there,” says Jeff Shuren, director of the agency’s device center.

The chain with arrows splits into two.
• Source: Shutterstock

The US Food and Drug Administration broke up its office that handled in vitro diagnostics and radiological health earlier this week, and the head of the agency’s device center is offering insight into why that happened.

The Office of In Vitro Diagnostics and Radiological Health “really had two flavors of technology – actually three – that sat in there,” said Jeff Shuren, director of the FDA’s...

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