FDA Permits Marketing of First Direct-to-Consumer App for Contraceptive Use

The FDA today permitted marketing of the first mobile medical app that can be used as a method of contraception to prevent pregnancy.¹ Natural Cycles Nordic AB’s app utilizes the fertility awareness method of contraception, and is intended for use in premenopausal women aged 18 and older.

The app, also called Natural Cycles, was designed for mobile devices by husband-and-wife physicists for their personal use.² The app 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.¹ Natural Cycles requires women to take their temperature daily using a basal body thermometer, and to enter the reading into the app, which also tracks a user’s menstrual cycle.¹

Basal body thermometers are more sensitive than regular thermometers and are used to detect a minor rise in temperature, of about half of 1 degree Fahrenheit, around the time of ovulation.¹ According to the FDA, Women using the Natural Cycles app for contraception should abstain from sexual intercourse or use protection (such as a condom) when the app displays a "use protection" message that indicates they may be experiencing a fertile day.

“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, MD, PhD, assistant director for the health of women in the FDA’s Center for Devices and Radiological Health, in a prepared statement.¹ “But women should know that no form of contraception works perfectly, so an unplanned pregnancy could still result from correct usage of this device.”

The Natural Cycles app was the first to be certified as a contraceptive in Europe.² The app currently has more than 500,000 users, who subscribe to the service for a monthly or annual fee, in 61 countries.²

Prior to the FDA's approval for marketing the Natural Cycles app, concerns about the efficacy were raised earlier this year by hospital officials in Stockholm, Sweden.³ Although the complaint indicated 37 women using the app had reported unplanned pregnancies,³ the app continues to be used by women in Europe.²

According to the FDA, clinical studies that evaluated the effectiveness of Natural Cycles for use in 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 1.8 in 100 women who use the app for one 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.¹ The app had a “typical use” failure rate of 6.5%, which accounted for women sometimes not using the app correctly.¹

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, according to the FDA. Natural Cycles does not provide protection against sexually transmitted infections.¹

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. The agency also released a Digital Health Innovation Action Plan last year to look at ways to provide clarity and find efficiency in how the agency regulates digital health technologies like the Natural Cycles app.

This article was updated August 13, 2018.

References

• FDA allows marketing of first direct-to-consumer app for contraceptive use to prevent pregnancy [news release]. Silver Spring, MD; August 10, 2018: FDA website. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm616511.htm. Accessed August 10, 2018.
• About Natural Cycles. Natural Cycles press kit. https://www.naturalcycles.com. Accessed August 10, 2018.
• Aungst T. 37 unwanted pregnancies raise raise concerns for family planning app. Pharmacy Times. https://www.pharmacytimes.com/contributor/timothy-aungst-pharmd/2018/02/37-unwanted-pregnancies-raise-concerns-for-family-planning-app/. Published February 3, 2018. Accessed August 10, 2018.