Business · 09/03/2001

FDA Releases Final Guidance for Class II Special Controls for Home Uterine Activity Monitors

The Food and Drug Administration (FDA) has published a final guidance document outlining special controls for home uterine activity monitors, which are expected to ensure the safety and effectiveness of these devices. The FDA is also reclassifying these devices from class III to class II, as announced in a separate final rule in this issue of the Federal Register.