Home uterine activity monitors
This article was originally published in The Gray Sheet
HUAMs for detection of preterm labor should be downclassified from Class III to Class II, FDA tentatively concludes in a July 30 Federal Register notice. The agency says it agrees with the recommendations put forth during an October 1997 meeting of its Obstetrics and Gynecology Devices Panel, which was convened to respond to a petition seeking downclassification of the devices submitted to FDA by Corometrics Medical Systems (1"The Gray Sheet" Oct. 13, 1997, p. 11). Following its review of public comments, the agency plans to approve or deny the petition via a letter to Corometrics. In a separate July 30 Federal Register notice, FDA issues a revised draft guidance document with advice on premarket submissions for HUAMs. The document is identical to an earlier draft of the guidance (2"The Gray Sheet" May 31, In Brief), except for a recommendation on the type of information that should be stored in HUAM patient registries
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Draft guidance document recently issued by FDA recommends that premarket submissions for the devices include results "from a small clinical study (n=25) that is designed to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)
HOME UTERINE MONITOR PATIENT REGISTRY AS CLASS II SPECIAL CONTROL WOULD ALLOW DOWNCLASSIFICATION TO CLASS II, FDA ADVISORY PANEL RECOMMENDS OCT. 7
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.
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