Medical devices; obstetrical and gynecological devices; classification of computerized labor monitoring system. Final rule.
The Food and Drug Administration (FDA) is classifying the computerized labor monitoring systems into class II (special controls). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled, "Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Computerized Labor Monitoring Systems," which will serve as the special controls for these devices. The agency is classifying these devices into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of these devices.
D004869:Equipment Safety / Q000145:classification*; D005260:Female; D005323:Fetal Monitoring / Q000145:classification / Q000295:instrumentation*; D006801:Humans; D007743:Labor, Obstetric; D011247:Pregnancy; D012815:Signal Processing, Computer-Assisted / Q000295:instrumentation*; D014481:United States; D014486:United States Food and Drug Administration; D018590:Uterine Monitoring / Q000145:classification / Q000295:instrumentation*