Ob/gyn panel to review Corometrics petition seeking downclassification for preterm use HUAMs.
This article was originally published in The Gray Sheet
Executive Summary
COROMETRICS HOME UTERINE MONITOR RECLASSIFICATION REQUEST TO BE REVIEWED BY PANEL at an Oct. 7 meeting in Rockville, Maryland. FDA's Obstetrics and Gynecology Devices Panel will discuss Corometrics Medical Systems' petition to FDA seeking downclassification to Class II (special controls) for home uterine activity monitors intended for use in preterm monitoring (less than 36 weeks gestation). HUAMs for use in detection of preterm labor currently are Class III, requiring premarket approval; when used to monitor full-term pregnancy (after 36 weeks), HUAMs are regulated in Class II.