The FDA recently cleared the first pregnancy contraception smartphone app for sale in the U.S. We are appreciative of the FDA’s continued forward movement with digital health products and approving mobile apps for medical applications. However, we have mixed reactions to the specific approval of what the FDA describes in a news release as “the first mobile medical application (app) that can be used as a method of contraception to prevent pregnancy.”

First some background.

The U.S. Food and Drug Administration regulates all medical products sold in the U.S. There are three medical device classes based on potential risk to patients and several routes to approval or clearance to market products.

In 1997, recognizing the increase in new technology in many realms including mobile medical apps, the FDA introduced a De Novo program to simplify and fast-track approval processes. In a De Novo FDA classification request, the applicant specifically asks the FDA to classify a device that has no similar products in the system into Class I or Class II for premarket certification based on risk. This certification allows sale in the U.S.

In 2013 the FDA issued guidance for mobile medical apps, establishing two classes, regulated and unregulated. The FDA pays particular attention to regulated apps intended as accessories to medical devices or apps that transform a mobile device into a regulated medical device. The FDA deems unregulated apps of low-to-moderate risk because they offer patient education or serve as reference aids. Getting the FDA nod to sell medical goods in the U.S. is not only a requirement but also marketing and advertising fodder. Since 2013 the FDA has approved hundreds of mobile medical apps.

In 2017 the FDA released the Digital Health Innovation Action Plan to clarify and improve the efficiency of the agency’s approval process.

Recently the FDA cleared the way for Natural Cycles to market its eponymous fertility awareness pregnancy contraception app. The FDA stated in its news release that the Natural Cycles app is the type of digital health technology for which it released 2017’s Digital Health Innovation Action Plan.

The Natural Cycles app relies on basal body temperature to track a woman’s menstrual cycle. Users must take their temperature each morning immediately upon waking and enter the reading into the Natural Cycle app. Based on temperature readings, the app identifies days as “Not fertile” in green letters or “Use protection” in red letters. During the red days, Natural Cycles instructs users to either abstain from having sex or use protection (such as a condom). So, one issue we have is the apparent contradiction in that what the publisher and the FDA both refer to as “a contraception method” tells users when they need to use a protective contraception method. Therefore, unless one abstains on red-letter days, Natural Cycles isn’t a stand-alone contraception method.

Natural Cycles submitted documentation to the FDA based on earlier studies stating that fertility-awareness is 99% effective when used perfectly and 93% effective with typical use. However, the CDC ranks fertility-awareness-based contraception methods among the “least effective” family planning methods, resulting in 24 unintended pregnancies among every 100 users with the first year of typical use. The CDC rating for fertility-awareness contraception methods would be 76% effective.

A meta-study of all studies published in English, Spanish, French, or German by June 2017 in MEDLINE, EMBASE, CINAHL, Web of Science, and published in September 2018 in Obstetrics & Gynecology found that studies of the effectiveness of fertility awareness-based contraception methods are few and of low to moderate quality, with widely varying pregnancy rates or probabilities.

According to the American College of Obstetricians and Gynecologists, between 12 and 24 women of every 100 could become pregnant in the first year when relying on fertility-awareness-based contraception with typical use, meaning 76% to 88% effectiveness, and the method is 95% to 99% effective only if used perfectly, meaning correctly and consistently every day.

Natural Cycles recommends that potential users do their own research and read about effectiveness fertility-awareness methods. However, the company states that the Natural Cycles method effectiveness is backed by clinical research and is “comparable to other methods.”

In an accompanying graphic Natural Cycles rates its own method’s effectiveness “high” and comparable to birth control pills, while rating condoms “medium” and IUDs “very high.”  The CDC’s published effectiveness rates are IUDs, 99.2-99.8%, depending on the material; birth control pills, 91%; male condoms, 18%; and fertility-based methods, 24%.

Our concerns are not that Natural Cycles received the FDA go-ahead, but that the agency apparently based that approval in part on effectiveness rates that are not supported by authoritative agencies and organizations in the field. The greater risk here is that the FDA clearance process may approve other digital health solutions that are not as safe and effective as they should be.