ORA Reorganization Includes New Geographic Divisions for Devices

May 22, 2017

The FDA’s Office of Regulatory Affairs officially began its transition to a program-based structure Monday, aligning inspection staff into seven product categories — and creating three new geographic divisions for oversight of devices.

The change follows nearly four years of planning. The previous regional configuration will be replaced with separate divisions covering medical devices and radiological health; pharmaceuticals; biologics; bioresearch monitoring; human and animal food; tobacco; and import operations.

The agency has published a series of fact sheets categorizing each office. The Office of Medical Device and Radiological Health Operations contains three divisions spanning the agency’s previous districts — OMDRHO staff will conduct inspections of medical devices and radiation-emitting products, as well as provide technical assistance across the ORA’s 20 district offices.

Jan Welch will serve as OMDRHO’s director, overseeing the Foreign Medical Device and Radiological Health Inspection Staff, Medical Device and Radiological Health Operations Staff, and Divisions of Medical Device and Radiological Health Operations I, II, and III, managing compliance activities and recalls. Welch previously led CDRH’s Office of Compliance.

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