United States:
FDA Issues Final Orders Classifying And Reclassifying Gastroenterology–Urology Devices Into Class II
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In the July 25, 2014, Federal Register, FDA reclassified implanted
blood access gastroenterology–urology devices from Class III
into Class II (special controls). The decision is based on
FDA's belief that the proposed special controls provide a
reasonable assurance of safety and effectiveness. In the same Federal Register, FDA classified the
implantable transprostatic tissue retractor system into class II
(special controls). Effective July 25, 2014, and August
25, 2014, respectively.
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