Good News for App Developers – FDA Won’t Regulate Wellness Apps

A bit of good news for fitness and health app developers; the Food and Drug Administration (FDA) will not regulate fitness trackers and certain mobile health apps according to its final guidance document. The report, General Wellness: Policy for Low Risk Devices was published on July 29, 2016.

More specifically, the FDA will not enforce its rules over apps and products that are intended only for “general wellness.” According to the FDA, the category of “general wellness” covers services or products that meet the following factors:

  1. Are intended for only general wellness use (which is more fully defined in the FDA guidance);
  2. Present a low risk to the safety of users and other persons; and
  3. In contrast, any app or product that claims to treat or diagnose a disease or condition will not be considered a general wellness product by the FDA and would be subject to regulation.

Navigating and complying with FDA regulations can be expensive and time-consuming. In fact, products regulated by the FDA must register with the agency, undergo review before they are marketed and sold, as well as meeting other regulatory requirements. For this reason, the FDA’s policy guidance exempting general wellness products and services is great news for developers in this area.

However, it is important to discuss the policy and how it may apply to your product with experienced legal counsel. This discussion should take place early in the development phase to determine if your app or product may be designed and marketed to avoid FDA regulation.

If you are a health and wellness app developer, and you would like more information about the release of this guidance from FDA or other legal questions, contact our law firm for an initial free consultation.