Mobile Medical Apps to Become Subject of the FDA – How to Prepare for the Regulations


With the rise of new health technologies comes the regulations. The US Food and Drug Administration (FDA) is among other things in charge of observing medical devices. In July 2011, the FDA released a draft guidance for mobile medical applications. The institution is now working on finalizing this document and the final guidance is said to be released in October this year. To prepare accordingly for upcoming regulations, startup accelerator Rock Health has released the so-called „FDA 101“ Rock Report to inform startups in the field of medical technology about the actions to take.

Basically, any application that turns a mobile device into a health device or is acting as a accessory to a health device will be in the eye of the FDA. There certainly are grey areas to this definition, which will hopefully be clarified in the final guidance lines.

While regulations always are a hassle, Rock Health points out that an FDA regulation can increase customer confidence, can help correct pre-market problems and improve the product as well as open new markets. On the other hand, the approval process could delay the product launch and become a market entry barrier for some of the apps in development. It is recommended to reach out to the FDA early. „Contact the FDA early to explain your idea, but developing a detailed regulatory strategy before you have a developed product is putting the cart before the horse“, warns Sridar Iyengar, co-founder of AgaMatrix.


To find out if your app in development should be on the radar of the FDA, Rock Health suggests to ask yourself the key question: „Is your app’s intended use to diagnose, treat, mitigate, cure or prevent a specific disease or condition?“ If so, the FDA will designate your product be either Class 1 (low risk to patient), Class 2 or Class 3 (high risk for patient).

Let’s face it: the upcoming regulatory processes mean more work for launching a mobile health device. Rock Health recommends to hire experienced consultants in the field of FDA regulations and also do proper documentation of the app development. Geoff Clapp, who acts as a mentor for Rock Health startups concludes, „Entrepreneurs should embrace, not fear, the FDA.“ The guidance would actually make digital health companies better companies.

Find the detailed Rock Report „FDA 101“ here.