FDA Releases Guidance on Mobile Medical Apps

The FDA released its final guidance earlier this fall on the types of mobile medical apps it will regulate. As expected, the FDA will have oversight on mobile medical apps that are used to diagnose, treat, or alleviate a disease as well as those that are used as an accessory to a medical device (e.g., displaying a CGM graph on a smartphone). Mobile medical apps that undergo FDA review will be assessed using the same regulatory standards applied to other medical devices – that sounds pretty strict to us. Thankfully, the agency will not regulate sales or use of smartphones or tablets, nor will it regulate app distributors such as the iTunes App store or Google Play store. Shortly after releasing the guidance, the FDA held a Twitter conversation online to answer questions, which we thought was an excellent way to communicate and connect with patients. You can read our summary of the tweetchat here, where the FDA acknowledged the transformative potential of mHealth, clarified what type of apps will require FDA review, and encouraged patients to continue the conversation by emailing mobilemedicalapps@fda.hss.gov.

Broadly speaking, the guidance will be helpful for people with diabetes to ensure safety of mobile medical apps and should bring more attention to the growing area of mHealth. According to the FDA, it has cleared 100 mobile medical apps over the past decade (including WellDoc’s BlueStar) – and 40 of those were cleared in the past two years. –NL/KC