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Restructuring of CDRH’s OC Proposed to Further Foreign Focus: Official

The FDA is considering the creation of a new Division of International Compliance Operations within CDRH’s Office of Compliance (OC) as part of the center’s efficiency drive and the agency’s increased international focus, CDRH officials say. The creation of the new office is part of a larger proposal to restructure the OC from a four- to five-division office, including a new Division of Premarket and Labeling Compliance, Jan Welch, CDRH’s deputy director of regulatory affairs, said.
Devices & Diagnostics Letter