The Food and Drug Administration will allow a pregnancy-prevention app to conduct marketing and advertising, USA Today reported Friday.
Natural Cycles, a Swedish app, is intended to be used as a form of contraception, using body temperature and menstrual cycles to predict fertility. The FDA was reviewing the app after it faced backlash in the U.K. and Sweden when women reported becoming pregnant while using the method.
"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, an FDA official. The algorithm-based app has a "typical use" failure rate of 6.5 percent, the FDA said, meaning that 6.5 in 100 women who use the app with an average amount of misuse will become pregnant. Birth control pills, in comparison, have a 9 percent failure rate with typical use.
Natural Cycles is marketed as the "world's first contraceptive app," touting its "natural, hormone free, and non-invasive" method, reports The Guardian. Users pay for a subscription, and use a special thermometer to track fertility. The app has more than 700,000 users around the world.
The FDA is creating new criteria for Natural Cycles to clarify what rules the app needs to follow to avoid regulatory issues. The agency is predicting more apps following in the footsteps of Natural Cycles, writing that future apps intended to prevent pregnancy will need to stick to the brand-new rules. Summer Meza