FDA Deems Mobile Health App a ‘Medical Device’

The U.S. Food and Drug Administration (FDA) has designated Ideomed Inc.’s mobile health app Abriiz a “medical device,” thereby allowing the app to connect to traditionally regulated products such as blood glucose monitors, pulse oximeters, scales and blood pressure cuffs.

The FDA is exercising “enforcement discretion” over the app; the designation identifies mobile medical devices that “are not subject to further FDA regulatory requirements at this time.” The agency’s recent Mobile Medical Applications report indicated the FDA would take a tailored, risk-based approach that focuses on the small subset of mobile apps that meet the regulatory definition of “device.” For many mobile apps the FDA deems as a “device” but pose minimal risk to patients and consumers, they will exercise enforcement discretions and will not expect manufacturers to submit premarket review applications or register their apps.

“The patient information provided by this expanded breadth of function, combined with the medication adherence, activity-tracking and health symptom data already captured by Abriiz provides a more comprehensive picture of a patient’s health and condition,” said Lisa Schutte, Ideomed’s vice president of Technology. “This enhances our ability to provide value to patients and care providers managing chronic conditions such as heart disease, diabetes, COPD and asthma.”

On the market since 2011, Abriiz has already been used in clinical trials and other implementations that have reported sustained daily engagement, improved health outcomes such as fewer emergency room visits, improvements in patient risk level stratification and reduced costs to insurers.

Leaders in the mobile health sector have responded positively to the FDA’s approach to regulating entrepreneurial development.

“Ideomed’s solution using smartphones to support chronic disease has the potential to significantly impact patient care in positive ways,” said Morgan Reed, executive director of the Washington, D.C.-based ACT|The App Association. “Ideomed’s Abriiz solution has already demonstrated success in early clinical trials. Helping patients better manage their chronic conditions means better health outcomes and lower costs for everybody. Given the 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.”

Ideomed officials are encouraged by the FDA review and its impact on Abriiz’s future.

“We are encouraged by the FDA’s approach to encouraging development in mHealth while rightfully ensuring the nation’s safety in their assessment process,” said Keith Brophy, Ideomed CEO. “The FDA’s response to our request affirms our expectation that the manner in which Abriiz surfaces consumer health device data is on the mark. We look forward to continuing to expand our approach integrating Apple’s HealthKit and other technologies to leverage a broader array of health device data in the future.”