Zdrowie i gospodarka · 30.07.1999
Home Uterine Activity Monitors Guidance; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Home Uterine Activity Monitors; Guidance for the Submission of 510(k) Premarket Notifications.'' Elsewhere in this issue of the Federal Register, FDA is publishing a notice of the panel recommendation to reclassify home uterine activity monitors (HUAM's) into class II (special controls) and FDA's tentative findings. FDA agrees that these monitors should be reclassified in class II, and the guidance that is the subject of this notice of availability is one of the special controls that FDA believes will provide reasonable assurance of the safety and effectiveness of these devices.