A Response from the FDA

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Abstract
SACHS et al., in discussing the Food and Drug Administration's approval of marketing of the Genesis Home Uterine Activity Monitor (HUAM), raise issues that require clarification.The authors contend that because the Genesis HUAM has not been shown to prevent premature births, it has no clinical value. We disagree. The FDA approved the device on the basis of its demonstrated ability to detect uterine contractions indicative of the onset of preterm labor, as evidenced by the degree of cervical dilation at the time of diagnosis. (It should be noted that in the supporting clinical study, none of the study subjects . . .

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