Cardiovascular and neurological devices; reclassification of two embolization devices. Final rule.
The Food and Drug Administration (FDA) is issuing a final rule to reclassify two embolization device types from class III (premarket approval) into class II (special controls). The agency is also changing the names and revising the identifications of these devices. The vascular embolization device (previously the arterial embolization device) is intended to control hemorrhaging due to aneurysms, certain types of tumors, and arteriovenous malformations. The neurovascular embolization device (previously the artificial embolization device) is intended to permanently occlude blood flow to cerebral aneurysms and cerebral arteriovenous malformations. FDA is reclassifying these devices on its own initiative on the basis of new information. FDA is taking this action under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990, the Food and Drug Administration Modernization Act of 1997, and the Medical Device User Fee and Modernization Act of 2002. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for these devices.
D002309:Cardiology / Q000145:classification / Q000295:instrumentation; D004621:Embolization, Therapeutic / Q000145:classification / Q000295:instrumentation*; D004867:Equipment Design; D004869:Equipment Safety / Q000145:classification; D006801:Humans; D009462:Neurology / Q000145:classification / Q000295:instrumentation; D014481:United States; D014486:United States Food and Drug Administration