Medical devices; exemptions from premarket notification and reserved devices; class I--FDA. Notice.
The Food and Drug Administration (FDA) is publishing a list of class I devices, subject to certain limitations, that will be exempt from premarket notification requirements on February 19, 1998. FDA is also publishing a list of those class I devices that FDA believes will remain subject to premarket notification requirements because they meet the new statutory criteria for premarket notification requirements. These lists do not include class I devices that have been previously exempted by regulation from the premarket notification requirements. FDA is taking this action in order to meet a requirement of the Food and Drug Administration Modernization Act of 1997 (the FDAMA). The agency requests comments on whether the list of class I devices that will remain subject to the premarket notification requirements should be modified.
D018795:Device Approval / Q000331:legislation & jurisprudence*; D004869:Equipment Safety; D004864:Equipment and Supplies / Q000145:classification*; D006801:Humans; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration