Home uterine activity monitors
This article was originally published in The Gray Sheet
Executive Summary
Draft guidance document recently issued by FDA recommends that premarket submissions for the devices include results "from a small clinical study (n=25) that is designed to show that the device produces tracings at the receiving station that are readable, i.e., that contractions are correctly perceived by the clinician." The document is intended to be used as a special control for the devices following their downclassification from Class III to Class II. In 1997, FDA's Obstetrics and Gynecology Devices Panel recommended the regulatory change, provided that special controls, including patient registries, are used ("The Gray Sheet" Oct. 13, 1997, p. 11)