Sunday, January 30, 2011
When Does a Smartphone Become a Medical Device?
In December 2010, the mHealth Regulatory Coalition issued a whitepaper, which is essential reading for anyone interested in this topic. The authors discuss what mobile health hardware and software will the FDA regulate and, if they are regulated, in what device classification will the FDA place them? They don’t come up with any answers, but they do illustrate the complexity of these questions.
The authors identify three areas for review:
Intended use: “To what extent can mHealth‐related products be excluded from FDA regulation by focusing their marketing campaigns on general improvements to consumer wellness, as opposed to focusing on the management or treatment of diseases such as diabetes and hypertension?”
Connected hardware: “To what extent do mobile phones and other generic communication hardware become FDA regulated medical devices simply because they are promoted for connection to a medical device?”
Software functionality: “To what extent does the FDA regulate software apps that are intended to reside on mobile phones, ordinary PCs, servers or perhaps in the cloud if they function to provide connections between communication hardware and medical devices or as repositories for health data?”
With the 54-page whitepaper, the Coalition has identified key topics for discussion and hopes to open a dialogue with the FDA.
How Will the FDA Cope?
With the volume of mobile health apps predicted to grow significantly, how would the FDA handle an increased regulatory workload? And if a pharma brand wants to create an app for patients, will they need to get it approved as a device first and then messaging reviewed by the Division of Drug Marketing, Advertising and Communications (DDMAC)? It will be interesting to see how this all plays out in the years to come.
What do you think?