Medical devices; device tracking; new orders to manufacturers--FDA. Notice.

The Food and Drug Administration (FDA) is announcing that the agency has issued new orders to manufacturers of devices that were subject to tracking. These new orders became effective on February 19, 1998, and require manufacturers to continue tracking the devices under the revised tracking provisions of the recently enacted Food and Drug Administration Modernization Act of 1997 (FDAMA). FDAMA allows the agency discretion in issuing orders to manufacturers to track devices that meet certain criteria. FDA is soliciting comments on what factors should be considered in exercising its discretion in determining whether the agency should not track a particular device, even though it meets the statutory criteria. FDA specifically is requesting comments on whether there are factors that FDA should consider in exercising its discretion in releasing certain devices listed in this notice from tracking requirements. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance that addresses device tracking under FDAMA, including the application of certain requirements under the current tracking regulations.