Iltifat Husain MD reviewed and contributed to this article
As developers continue to create innovative ways for clinicians and patients to interact while on the go, many wonder whether the mobile app they are designing will require FDA approval or be ready to go to market right out of the gate. Making that determination will depend in large part on whether the application meets the FDA’s criteria as a medical device. A recent analysis of the legal landscape by Keith Barritt, an attorney with Fish & Richardson in Washington, DC, can help shed some light on the situation.
In an article titled, “How to avoid FDA regulation for your mobile medical app” — Barritt explains that if the agency decides your app falls into the medical device category, it will require an FDA review before it can go to market legally. A medical device can include software that is intended for use in one of three situations: To diagnose a disease or other condition; cure, mitigate, prevent, or treat a disease; or affect a bodily function or structure.
A recent example of this is Roche’s FDA approved ACCU-CHECK diabetes app. ACCU-CHECK is the first FDA approved app that gives specific insulin dosing recommendations based on your blood sugar checks and carbohydrate intake.
That does not mean any mobile app that is designed to improve a person’s health is by default a medical device in the eyes of the FDA. In fact, the agency recently explained that: “FDA does not even intend to examine whether ‘low-risk general wellness’ products are devices or whether they simply comply with the Food, Drug, and Cosmetic Act” says Barritt.
The agency’s draft guidance includes 2 categories of products in this low risk category: Those designed to encourage people to maintain or develop a general state of health or healthy activity. The second category includes apps that would promote, track, and encourage people to reduce their risk of certain chronic disorders, or live well with those disorders. These 2 categories cover the majority of health apps available for iOS and Android platforms – think blood pressure trackers and fitness apps.
The fact that this article was written at all reminds us that the majority of developers in the medical app space are doing their best to avoid federal oversight. That’s understandable – it adds a lot of cost and delays entry into the market. And while most of these apps don’t pose the type of risk that the FDA is concerned about, there is one risk clinicians and patients should keep in mind – the risk of wasted time and money that goes along with a poorly designed medical app. As Mr. Barritt reminds us, unlike medications or devices, no agency is checking out health apps before they come to market. It’s important that clinicians and patients thoughtfully evaluate these apps themselves and consider factors like the evidence underlying individual apps, their information sources, and privacy when deciding which app is most likely to fill their clinical need.
Paul Cerrato is an experienced medical writer who is collaborating with iMedicalApps to help us bring you news on digital health faster and more effectively.