FDA permits marketing of first mobile app for contraception
The app Natural Cycles has become the first contraceptive app to be granted marketing approval in the United States.
The first mobile medical application to be used as a method of contraception has been granted marketing approval by the US Food and Drug Administration (FDA).
The Swedish app, Natural Cycles, which is already certified for contraception in the EU, requires women to take their temperature daily using a basal body thermometer immediately upon waking up in the morning, and enter the reading into the app.
The sensitive thermometer can detect a minor rise in temperature of approximately half of one degree Fahrenheit (or 0.28 in Celsius) around the time of ovulation. When this is detected, the app will advise women to either abstain from sex or use protection as they are most likely to be fertile during those days.
“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, assistant director for the health of women at 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 of Natural Cycles as a method of contraception involved 15,570 women who used the app for an average of 8 months. The app had a “perfect use” failure rate of 1.8%, which means that 1.8 women in every 100 who use the app for a year will become pregnant because they have 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.
The “typical use” failure rate was 6.5%, which accounted for slip-ups when using the app.
In the EU, Natural Cycles is a certified and CE-marked medical device of class IIb intended to be used for contraception, which places it in the same risk category as a condom.
Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2018.20205315
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