Neurosurgical materials and devices

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Abstract
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 neurosurgeon is provided with a reference source regarding past and present neurosurgical activities in the materials and devices field. When the USA 1976 Medical Device Amendments were enacted 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.

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