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Medical Devices / Regulatory Affairs

FDA to Begin ORA Reorganization in Mid-May

April 7, 2017
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After nearly four years of discussion and expectation, the FDA will begin its inspection reorganization in mid-May.

Beginning May 15, the current five-region structure will be replaced with six program areas, covering medical devices and radiological health; pharmaceutical quality; biological products; bioresearch monitoring; human and animal food; tobacco and a program for import operations.

“Program alignment is to establish these more vertical commodity-specific programs so you just have a device inspector, that is all they do—and that will allow them to better focus and have the right expertise and training,” CDRH Director Jeff Shuren told a House hearing on medical device user fees. “That will start to drive more consistency and more timeliness in the conduct of inspections.”

The Office of Regulatory Affairs will keep its 20 existing districts. District directors will keep their responsibilities, but will also specialize in one program as division directors, the FDA said. The FDA has no plans to close offices or relocate personnel.

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