GRAND RAPIDS ? Ideomed a developer of mobile health solutions, has received word from the Food & Drug Administration that its mobile health app Abriiz meets the definition of a medical device for which the FDA intends to exercise Enforcement Discretion.
This designation identifies mobile medical devices that ?are not subject to further FDA regulatory requirements at this time.?
This news clears the way for Abriiz to be connected to other FDA-regulated devices including blood glucose monitors, pulse oximeters, scales, blood pressure cuffs and more.
“We are encouraged by the FDA’s well-balanced approach to encouraging innovative development in mHealth while rightfully ensuring the nation’s safety in their assessment process,? said Keith Brophy, Ideomed?s 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.”
In its recent Mobile Medical Applications report, the FDA indicated that its stance would be to 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 that meet the regulatory definition of a ?device? but pose minimal risk to patients and consumers, the FDA will exercise enforcement discretions and will not expect manufacturers to submit premarket review applications or to register and list their apps with the FDA.
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.
