The US Food and Drug Administration (FDA) has cleared for marketing the first direct-to-consumer mobile medical app that can be used for birth control, the agency said.
The "fertility awareness" app, called Natural Cycles (Natural Cycles Nordic AB), contains an algorithm that calculates the days of the month a woman is likely to be fertile based on daily body temperature readings and menstrual cycle information. It is intended for use by women aged 18 years or older.
"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. But women should know that no form of contraception works perfectly, so an unplanned pregnancy could still result from correct usage of this device," Terri Cornelison, MD, PhD, assistant director for the health of women in the FDA's Center for Devices and Radiological Health, said in a news release.
With Natural Cycles, women check their basal body thermometer daily, in the morning immediately upon waking and to enter the reading into the app, which also tracks women's menstrual cycle. Women using the app for contraception should abstain from sex or use protection when they see "fertile day" displayed on the app, which is typically 4 or 5 days a month.
Clinical studies evaluated the effectiveness of Natural Cycles as a contraceptive method in 15,570 women who used the app for an average of 8 months. The app had a "perfect use" failure rate of 1.8%, meaning 1.8 in 100 women who use the app for 1 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, the FDA said.
The app had a "typical use" failure rate of 6.5%, which accounted for women sometimes not using the app correctly by, for example, having unprotected intercourse on fertile days.
The FDA said 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.
The FDA reviewed the Natural Cycles app through the de novo premarket review pathway, a regulatory pathway for novel, low-to-moderate-risk devices of a new type.
According to the company's website, the Natural Cycles app can be purchased through the Apple store or Google Play on a yearly subscription basis for $79.99 a year (includes oral basal thermometer) or monthly for $9.99 per month. They also offer a free trial period of 1 month.
Cite this: FDA OKs First Direct-to-Consumer Birth Control App - Medscape - Aug 10, 2018.
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