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Regulatory News In Brief

Agency issues proposed orders to reclassify intra-aortic balloon and control systems, tuberculosis IVDs and stair-climbing wheelchairs. Industry mainly supports FDA’s communications draft guidance. More regulatory news.

FDA issued a proposed order June 19 to maintain class III status and require the filing of a PMA for intra-aortic balloon and control system devices indicated for septic shock or pulsatile flow generation, while reclassifying devices indicated for acute coronary syndrome, cardiac and non-cardiac surgery, or complications of heart failure to class II with special controls.

The proposal for the class III, pre-amendment devices are consistent with recommendations from FDA’s Circulatory System devices advisory panel last December. (See Also see "FDA Panel Recommends Split Classifications...

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