The U.S. Food and Drug Administration opted to use its enforcement discretion by not regulating mobile health app Abriiz from Ideomed. This case provides an early glimpse at how the agency will enforce its mobile medical app guidelines that were finalized just last fall.
There are several iterations of Abriiz tailored to specific conditions such as diabetes, asthma and cardiovascular problems. The mobile app and web-interface allow patients to set reminders, track, analyze and share data that's specific to their condition. It can also connect to activity bands and Wi-Fi scales to bring in data; Ideomed is also working on adding a glucose meter.
According the company, the FDA sent it a letter specifying that Abriiz is a medical device but that the agency will not be regulating it. The final guidance from FDA released in September 2013 provides for "enforcement discretion" when it comes to apps that are medical devices, but that are also relatively low risk to patients.
Ideomed CEO Keith Brophy posted excerpts from the FDA letter on the company's blog. It read, "We have reviewed the above referenced Request for Information, submitted in accordance with Section 513(g) of the Federal Food, Drug and Cosmetic Act, regarding the regulatory requirements applicable to Abriiz". And continued, "...we believe that Abriiz is a medical device as that term is defined in section 201(h) of the Act."
Finally, the agency concluded: "...we believe that Abriiz is a mobile medical application allowing a user to collect, log, track and trend data ... Therefore, at this time, we do not intend to subject your device to any regulatory requirements..."
The company is interpreting this as clearing the way for Abriiz to be connect to various FDA-regulated devices including blood glucose monitors, pulse oximeters, scales and blood pressure cuffs, without itself being subject to agency regulation.
Abriiz started out on the market in 2011 and has been used in clinical trials. The company says it sustains daily patient engagement and improves health outcomes.
"Given the remarkable promise that Abriiz holds, we are not surprised it was one of the first mobile health solutions to be formally reviewed by the FDA following the introduction of its Guidelines on Mobile Medical Applications," Morgan Reed, Executive Director of the Washington, DC-based ACT: The App Association, said in a statement.
- here is the Ideomed blog post
- and here is their press release
- here are the final FDA guidelines for mobile medical apps from September