FDA Approves its First Digital Form of Birth Control

The Food and Drug Administration (FDA) approved an app to market itself as a form of birth control in the U.S. Natural Cycles, a Swedish app that has been in use to prevent pregnancy in some European countries, is the first app to be approved in America as a digital contraceptive.

Natural Cycle works by using an algorithm to calculate the window of days each month a woman is most fertile and likely to conceive based on information given by its user, such as daily body temperature and monthly menstrual cycles. The app can also be used to determine which days women should avoid having sex or use protection in order to avoid pregnancy.

The FDA evaluated 15,570 clinical studies involving women who used the app for an average of eight months, and concluded the app has failure rate of 1.8% for “perfect use” and a 6.5% failure rate for “typical use.” For comparison, according to the Center for Disease Control (CDC), condoms have an 18% margin of error.

"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, M.D., Ph.D., 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."

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