Reguatory Affairs Professional Society raps.org
Posted 10 August 2018 | By Ana Mulero
A Swedish startup company obtained US Food and Drug Administration (FDA) approval Friday for the country’s first mobile medical app indicated for contraceptive use.
The Natural Cycles app features an algorithm that supports fertility awareness by gauging days of likely fertility based on menstrual cycles and daily body temperature data submitted by users.
To approve the app via the de novo pathway, the agency evaluated results from clinical studies that showed failure rates of “perfect use” at 1.8% and of “typical use” at 6.5%. The studies involved a total of 15,570 women who used the app for eight months on average.
Natural Cycles Nordic AB received CE Marking last year to market the app, which is intended for premenopausal women who are at least 18 years old, in the EU in the same risk category as condoms. Reports followed with news about some users’ unplanned pregnancies.
“But women should know that no form of contraception works perfectly, so an unplanned pregnancy could still result from correct usage of this device,” said Terri Cornelison, assistant director for the health of women at FDA’s Center for Devices and Radiological Health.