Today, understanding whether digital health software or apps are actively regulated as medical devices by the U.S. Food and Drug Administration (FDA) involves a complicated crowdsourcing of statutes, regulations, and a web of guidance documents. Critical to understanding the reach of FDA’s regulatory authority and oversight is understanding that both the marketing terms used and the functionalities of the software or apps drive the determination whether and how FDA will regulate those products. FDA regulates software and apps meeting the statutory definition of a medical device which, with a few exceptions, includes anything intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease. Below is a quick guide to the regulatory status of consumer software and apps:
- Mobile Medical Apps: Mobile apps that are medical devices and whose functionality could pose a risk to safety if the app were to not function as intended receive active FDA regulation and oversight. To manage FDA resources, the Agency said it will not actively regulate apps that only do the following: Accessing disease information or facilitating patient-doctor communications. Apps that promote healthy behaviors or enable logging or tracking health or lifestyle information are not considered devices.
- Low-Risk General Wellness Products: There are two categories of low-risk general wellness products: (1) those that maintain or encourage a general state of health without reference to a specific disease; and (2) those that sustain or offer general improvement to functions associated with a general state of health for chronic diseases (including uses that reduce the risk of or that help living with a chronic disease). Products in the first category are not considered devices and products in the second category are not actively regulated.
- Patient Decision Support Software: While FDA’s guidance remains in draft form, it provides that FDA will not actively regulate patient decision support software that does all of the following: (1) displays or analyzes patient information; (2) supports or provides independently verifiable recommendations about disease prevention, diagnosis, or treatment; and (3) does not acquire, process, or analyze images or signals from devices.
Importantly, marketing claims and representations for software or apps that might otherwise fall outside of device regulation or qualify for enforcement discretion can inadvertently land a technology squarely under FDA’s active regulation and oversight. Designing software, apps, and marketing materials with this in mind can help ensure an expeditious path to market.