Zdrowie i gospodarka · 25/02/2004

Cardiovascular and Neurological Devices; Reclassification of Two Embolization Devices

The Food and Drug Administration (FDA) is proposing to reclassify two embolization devices to change the names of the devices, revise the identification of the devices, and reclassify the two devices from class III (premarket approval) into class II (special controls). The vascular embolization device (previously the arterial embolization device) is intended to control hemorrhaging due to aneurysms, certain 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. These reclassifications are being proposed under the agency's own initiative 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 SMDA), the Food and Drug Administration Modernization Act of 1997 (FDAMA), and the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) based on new information. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of the draft guidance document that