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CDRH Reorganization Puts Radiological, IVD Functions Under One Umbrella

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An Oct. 1 CDRH reorganization brings radiological and mammography devices and in vitro diagnostics under a new Office of In Vitro Diagnostics and Radiological Health. In vitro diagnostics previously were regulated by the Office of In Vitro Diagnostics, which since 2010 had also handled premarket clearance and approval of radiological devices.
Devices & Diagnostics Letter