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CDRH Highlights Fiscal 2008 Enforcement Priorities

November 13, 2007

Computer-controlled fluoroscopy X-ray systems are at the top of CDRH’s fiscal 2008 enforcement priorities, according to David Kalins, special assistant to the director in CDRH’s Office of Compliance.

Troponin, rapid influenza and prothrombin time tests, as well as heating pads and disposable infusion pumps, also will be enforcement priorities in 2008, Kalins said at the Second Annual FDA Inspections Summit.

The agency based the priorities on concerns identified in premarket and postmarket data.