Neurosurgical materials and devices. Report on regulatory agencies and advisory groups.
The current status of voluntary consensus standards writing procedures in neurosurgery and the current progress of government efforts to regulate materials and devices are described. A survey of the national and international standards writing bodies is presented, along with an introduction to related organizations and agencies and nomenclature. The intent of this review is to provide the neurosurgeon with a reference source regarding past and present neurosurgical activities in the materials and devices field. When President Ford signed the 1976 Medical Device Amendments on May 28, 1976, the Food and Drug Administration assumed direct legal authority to control medical devices and potentially assumed the power to regulate those professionals using them.
D006077:Government Agencies; D007390:International Agencies; D007883:Legislation, Medical; D009493:Neurosurgery / Q000592:standards*; D012955:Societies, Medical; D013523:Surgical Equipment / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration