Neurological devices; classification of human dura mater. Final rule.
The Food and Drug Administration (FDA) is classifying human dura mater intended to repair defects in human dura mater into class II (special controls). This action is being taken to establish sufficient regulatory control to provide reasonable assurance of the safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled "Class II Special Controls Guidance Document: Human Dura Mater" that will serve as the special control for this device.
D018795:Device Approval / Q000331:legislation & jurisprudence; D004388:Dura Mater; D004869:Equipment Safety; D006801:Humans; D007883:Legislation, Medical; D016378:Tissue Transplantation / Q000145:classification* / Q000331:legislation & jurisprudence; D014481:United States; D014486:United States Food and Drug Administration