Last week’s FDA approval of Natural Cycles, a mobile medical app, makes available in the US a personal and discreet form of birth control that’s been available to EU women since August 2017. The app uses early morning temperature measurements logged by the user to determine her position in the menstrual cycle, allowing her to make appropriate choices to avoid (or encourage) pregnancy. This is the first fertility app approved by the FDA, and because it used the De Novo premarket review pathway, future fertility apps will be able to use the 510(k) review process for approval as long as they can demonstrate substantial equivalence to Natural Cycles as the predicate device. The app does not prevent STDs (naturally), and has a typical use failure rate of 6.5%, the rate which accounts for those times when users don’t use the app correctly. Compare this to the CDC’s published failure rates of 28% for typical fertility-awareness based methods, ~20% for condoms, 9% for contraceptive pills, and < 0.1% for IUDs. The biggest disadvantages are the subscription price, which is $80/year, and the discipline of logging daily temperature measurements. One important point to note – FitBit announced “Female Health Tracking” in late May. While their marketing focuses on menstrual health related issues, will they be far behind with a 510(k) application?

Text Copyright © 2018 Katrina Rogers