Published: Thu, August 16, 2018
Medical | By

FDA approves marketing for a contraception app

FDA approves marketing for a contraception app

The mobile app, Natural Cycles, is used by more than 900,000 women across the globe to prevent pregnancy.

The Swedish app, Natural Cycles, which is already certified for contraception in the European Union, 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. During clinical studies evaluating its effectiveness, more than 15,000 women used the app, with a reported failure rate of 1.8 percent with flawless use-meaning 1.8 out of 100 women doing exactly what the app told them to every day for a year still got pregnant.

"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 in FDA's Center for Devices and Radiological Health, in a press release. Along with this authorization, the FDA is establishing criteria, called special controls, which clarify the agency's expectations in assuring the accuracy, reliability and effectiveness in preventing pregnancy using apps indicated for contraception. The failure rate increased to 6.5% when accounting for women sometimes not using the app correctly, including having unprotected sex on fertile days.

The algorithm identifies and displays "green" or "red" days, green for not fertile and red for fertile.

To use it, women take their body temperature using a basal thermometer immediately when waking up in the morning and enter it into the app. A yearly subscription comes with a high-sensitivity basal thermometer. The typical use failure rate is right on par with the oral pill, which is around 9 percent, according to the Centers for Disease Control. (Though the Natural Cycles app does not protect against Sexually Transmitted Infections.) It works using a contraceptive method known as fertility awareness, in which women are aware of which days each month they are likely to be fertile and can get pregnant.

The app was reviewed through the de novo premarket review pathway, a streamlined process for novel, low-to-moderate-risk devices of a new type.

Also Friday, the FDA approved the first vaginal ring contraceptive that can be used for an entire year.

Natural Cycles Nordic AB is based in Switzerland.

Natural Cycles may be suitable for women who are looking for a natural method of contraception and have a lifestyle that enables them to take their temperature first thing most mornings.

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