FDA to mull reclassification for some circulatory system devices

Should intra-aortic balloon pump devices be regulated under Class III guidelines--the most stringent--with PMA approval, or adjusted to Class I or II, which entails an easier process? What about cardiopulmonary bypass blood pumps? Should they be adjusted in a similar way? The FDA has been mulling these issues for some time, and now the Circulatory System Devices Panel of the agency's Medical Devices Advisory Committee will meet Dec. 5 and 6 to consider these and other devices up for possible changes in regulatory reclassification, and make recommendations. The two-day public hearing will include expert testimony. More

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