HOME UTERINE MONITOR PATIENT REGISTRY AS CLASS II SPECIAL CONTROL WOULD ALLOW DOWNCLASSIFICATION TO CLASS II, FDA ADVISORY PANEL RECOMMENDS OCT. 7
This article was originally published in The Gray Sheet
Executive Summary
Using home uterine activity monitor patient registries as a Class II special control would help provide reasonable assurance of safety and effectiveness to justify downclassification of the devices for use in preterm monitoring, FDA's Obstetrics and Gynecology Devices Panel concluded at an Oct. 7 meeting in Rockville, Maryland. The panel unanimously voted (7-0) to recommend downclassification from Class III.