FDA Approval of a Contraceptive Mobile App Shows Why It is Not Worth it 
[Posted on: Thursday, August 16, 2018]

This week FDA approved the first mobile contraceptive app created by a Swedish startup. The app basically uses a calendar connected to temperature reading submitted by the users to calculate their menstrual cycle and predict more fertile days than others. There are several reasons why this approval may be both a gimmick and a significant regulatory achievement but, in either case, getting FDA approval is an overkill. In terms of significant achievement, Natural Cycles, has the bragging rights to be the first of its kind to get both FDA approval and a CE mark as a medical device in the same category as condoms. The company did comprehensive clinical trials to support its claims and went through a vigorous regulatory process for the medical device approval in the US via the de novo 510k pathway. But that’s where it ends. There are multiple reasons why this was not the best approach to market the app. First, women keep track of their menstrual cycles and are generally able to estimate their highly fertile days based on generally available information. The app digitizes this process and provide independent verification but does not give any new information to the women. So, its commercial value is limited at best. Second, since the rationale is based on generally available information, it should be relatively easy for others to create similar apps and further erode the commercial viability of the FDA-approved app. In fact, there are hundreds of fertility tracker apps freely available on all mobile platforms none of which needed or went for FDA approval. All these apps are considered general health awareness  devices and hence are not regulated by the FDA. Although getting an FDA approval for the app did give it its fifteen minutes of fame but that’s about it. On the other hand, by making stronger claims supported by the FDA approval, the company set itself up for frivolous law suits. The creators of the FDA approved app have already been sued by women claiming that they got pregnant despite following the app’s recommendations. For all other app developers this could be tale of caution. Getting FDA approval is only recommended when that is the only way to market a product. Since most mobile health apps can be considered digitization of generally available information, FDA does not require prior approval to market. FDA has taken a very liberal approach to mobile apps. Most apps do not require premarket approval under the current regulatory regime. Even apps that seem to treat major diseases are given a pass. So, before going for a longer, expensive and painful process for FDA premarket approval, it is imperative that the developers doing a common-sense check as to if that is the best route to market. For healthcare apps, it is generally not.