CDRH Highlights Fiscal 2008 Enforcement Priorities

Computer-controlled fluoroscopy X-ray systems are at the top of the Center for Devices and Radiological Health’s (CDRH) 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.

Kalins explained how the agency determines its priorities for facility inspections. If a firm initiates a product recall or receives a warning letter, it is almost guaranteed the FDA will inspect its facilities. Agency trending of medical device reports, intelligence gained from competitors and information provided by whistle-blowers are used to determine inspection priorities as well.