FDA grants Natural Cycles' contraception app de novo marketing approval

By Dave Muoio
03:33 pm

The FDA announced today that it will allow marketing of Natural Cycles’ contraception app in the US for pre-menopausal women aged 18 years and older. Previously approved in the UK and currently the subject of investigation by multiple regulatory agencies, the algorithm-driven app helps users track their menstrual cycle and informs them when they are most fertile.

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

Cofounded by Dr. Elina Berglund, a nuclear physicist who worked with CERN to find the Higgs Boson particle, and her husband Dr. Raoul Scherwitzl, Natural Cycles is a subscription service that includes an app and a basal thermometer. By taking their temperature in the morning and submitting additional information about their cycle, the app’s algorithm generates insights about the user’s daily fertility. The product is CE certified as a contraceptive in Europe, and raised $30 million in funding last November.

The Natural Cycles was reviewed through the FDA’s de novo premarket review pathway for low-to-moderate-risk devices. In its announcement, the agency noted that it will be establishing “special control” criteria to make clear its accuracy, reliability, and pregnancy prevention effectiveness expectations for this and future contraception apps.

Data supporting the decision included clinical studies of 15,570 users who used the app for an average of eight months. In these, the Natural Cycles demonstrated a “perfect use” failure rate of 1.8 percent, implying that 18 women in 1,000 using app correctly for a year will become pregnant, and a “typical use” failure rate of of 6.5 percent for those occasionally using the app incorrectly.

The FDA’s announcement is good news for a company that’s been running into some controversy in the UK as of late.

Just last week, the Guardian reported that the UK’s Advertising Standards Authority had opened a formal investigation into the Swedish company after receiving three complaints regarding paid Facebook adverts that included effectiveness claims requiring “robust substantiation.” Earlier in the year, Södersjukhuset hospital in Stockholm, Sweden reported the system to Sweden’s Medical Products Agency (MPA) after it found that 37 women among 668 had experienced an unplanned pregnancy while using the app. Both investigations are still ongoing.

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