FDA modernization act of 1997: guidance on medical device tracking; availability--FDA. Notice.
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Guidance on Medical Device Tracking." This guidance is intended to provide guidelines to manufacturers and distributors about their responsibilities for medical device tracking under the Food, Drug and Cosmetic Act (the act), as amended by the Food and Drug Administration Modernization Act (FDAMA). This guidance addresses what statutory and regulatory tracking requirements have changed and what requirements remain the same under the FDAMA amendments. The agency requests comments on this guidance. Elsewhere, in this issue of the Federal Register, FDA is announcing new orders to manufacturers of devices that were subject to tracking.
D018795:Device Approval / Q000592:standards*; D004864:Equipment and Supplies / Q000592:standards; D017408:Guidelines as Topic; D011358:Product Surveillance, Postmarketing / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration