FDA News

FDA authorizes marketing of fertility awareness app

The FDA has permitted marketing of a fertility awareness app that can be used as a method of contraception.

This is the first authorization for a direct-to-consumer app for contraceptive use to prevent pregnancy, according to a news release from the FDA.

The Natural Cycles app, which is intended for use in premenopausal women aged 18 and older, calculates the woman’s likelihood of fertility based on daily basal body temperature and menstrual cycle information.

In clinical studies involving 15,570 women, the app had a “perfect use” failure rate of 1.8% and a “typical use” failure rate of 6.5%. Typical use failures occur when women do not use the app correctly; perfect use failures occur when the app is used correctly.

“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 the release.

 

 

The FDA has permitted marketing of a fertility awareness app that can be used as a method of contraception.

This is the first authorization for a direct-to-consumer app for contraceptive use to prevent pregnancy, according to a news release from the FDA.

The Natural Cycles app, which is intended for use in premenopausal women aged 18 and older, calculates the woman’s likelihood of fertility based on daily basal body temperature and menstrual cycle information.

In clinical studies involving 15,570 women, the app had a “perfect use” failure rate of 1.8% and a “typical use” failure rate of 6.5%. Typical use failures occur when women do not use the app correctly; perfect use failures occur when the app is used correctly.

“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 the release.