Navigating FDA regulations of medical software


BOSTON—People think it can’t be true, but software has been regulated for decades, said Bradley Merrill Thompson, JD, attorney with Epstein, Becker & Green, during a session on regulatory decisions at mHealth + Telehealth 2015.

The key word in the FDA’s definition of devices is intent, he explained. A company’s intention in selling a given product and what customers are supposed to use it for are important. “Within the FDA space, what you say impacts how it’s treated,” said Thompson.

The FDA published a final draft of its guidance on medical apps in February, but Thompson said a lot of people are still using the 2013 version. There are very significant differences between the two.

The FDA uses a pyramid divided into three categories: regulated, unregulated and a middle tier with enforcement discretion.

Thompson cited the case of Biosense, which in 2013 came out with an app for urinalysis. The app got a lot of media attention and Biosense posted a disclaimer on its website saying that it is not a medical device. They got an enforcement letter from the FDA because the app did the same thing as a medical device. “A lot can be based on what FDA has regulated before,” he said.

A lot of apps are viewed as an extension of some other type of device by connecting to it to gain control, use in active patient monitoring or analyze medical device data. This last scenario “is the one that gets a lot of folks,” says Thompson. “The FDA says if that functionality were on the device itself it would be regulated. Moving to the phone doesn’t change the risk proposition. If the analysis is wrong, then what good is it that the original device worked correctly?”  

Clinical decision software falls under the category of software analytics. The FDA has promised special guidance dedicated to this topic which is due by Sept. 30. Guidance trying to divide the line between analytics that deserve regulation and those that don’t is going to be pretty important, Thompson said.

The FDA’s draft guidance on mobile apps is “extremely important,” he said. “It is really a huge step in a positive direction of saying ‘we at the FDA want to encourage Americans to live healthier lifestyles and want tools to empower them to do so.’ They are pulling back the reins.”

The goal is tools that help people reduce the risk of certain chronic diseases or conditions, or help them live well with them. One important driver is that the scientific community is firmly committed to the association of diet and diabetes, for example, Thompson said. “If the scientific community hasn’t bought into a newer concept, you can’t do it.”

Permitted functionalities include promoting, tracking, and/or encouraging healthy choices. The functions have to be low risk, however. An app to help people with diabetes, for example, doesn’t treat the disease. “There’s a gentle, subtle line here,” Thompson said. “It has to be good for general health and not crossing the line and saying in the app or promotion of the app that it’s good for managing diabetes.” The seriousness of disease has a major impact on how the FDA will treat the products, he noted.

The law is not always clear when it comes to enforcement discretion. The FDA decided to exempt low-risk devices, however, they may or may not meet the definition of medical device. The agency also can change its exemption but will only change it prospectively.

“The FDA is taking a shortcut” with enforcement regulation, Thompson said. It takes a lot of time and money to change the regulations through rulemaking so they use guidance instead.