FDA clears mobile contraceptive app for women
A federal agency has approved an app that analyzes a woman’s basal body temperature and identifies when ovulation has occurred.
The Food and Drug Administration has cleared the app as a method of contraception to prevent pregnancy. Called Natural Cycles, it leverages an algorithm that calculates fertile days when protection or abstinence is required.
Intended for use in pre-menopausal women aged 18 and older, users measure their basal temperature in the morning—five values per week are recommended—and then enter the data into the app, which gets to know their individual menstrual cycle. With one to three cycles of measurement, the app has enough data to confirm when ovulation has occurred and accurately predict fertility.
The FDA reviewed the app from Swedish fertility software vendor Natural Cycles Nordic AB through the de novo premarket review pathway, a regulatory process for novel, low-to-moderate-risk devices of a new type.
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“Consumers are increasingly using digital health technologies to inform their everyday health decisions, and this new app can provide an effective method of contraception if it’s used carefully and correctly,” said Terri Cornelison, MD, assistant director for the health of women in the FDA’s Center for Devices and Radiological Health. “But women should know that no form of contraception works perfectly, so an unplanned pregnancy could still result from correct usage of this device.”
According to the FDA, clinical studies involving 15,570 women showed that the app has a perfect use failure rate of 1.8 percent, which means 1.8 in 100 women who use the app for one year will become pregnant because they had sexual intercourse on a day when the app predicted they would not be fertile or because their contraceptive method failed when they had intercourse on a fertile day.
In addition, the regulatory agency noted that the app has a typical use failure rate of 6.5 percent, which accounted for women sometimes not using the app correctly by—for example—having unprotected intercourse on fertile days.
The FDA warns that Natural Cycles “should not be used by women who have a medical condition where pregnancy would be associated with a significant risk to the mother or the fetus or those currently using birth control or hormonal treatments that inhibit ovulation” and that the app “does not provide protection against sexually transmitted infections.”