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HOME UTERINE ACTIVITY MONITOR EFFICACY ENDPOINT OF CERVICAL DILATION

This article was originally published in The Gray Sheet

Executive Summary

HOME UTERINE ACTIVITY MONITOR EFFICACY ENDPOINT OF CERVICAL DILATION should remain in FDA's draft premarket testing guidelines for the devices, the agency's Obstetrics and Gynecology Devices Panel recommended at a Sept. 2 meeting in Rockville, Maryland. In a 3-2 vote, the panel said that the measurement of cervical dilation at the time of preterm labor diagnosis should continue to be the primary endpoint in FDA's "benchmark" study design for HUAMs used to diagnose preterm labor.

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