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FDA allows marketing of first CGM mobile medical apps
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The FDA today allowed marketing of the first set of mobile medical apps that allow patients with diabetes to automatically and securely share data from a continuous glucose monitor with others by using an Apple mobile device, according to a news release from the agency.
“This innovative technology has been eagerly awaited by the diabetes community, especially caregivers of children with diabetes who want to monitor their glucose levels remotely,” Alberto Gutierrez, PhD, director of the office of in vitro diagnostics and radiological health at the FDA’s Center for Devices and Radiological Health, said in a press release. “Today’s marketing permission paves the way for similar technologies to be marketed in the United States.”
Alberto Gutierrez
The data-sharing capability available through the Dexcom Share Direct Secondary Displays system allows remote monitoring through a legally marketed device. Similar devices were previously obtainable through open-source efforts but not in compliance with regulatory requirements, according to the release.
The Dexcom system displays data from the G4 Platinum CGM System via a pair of apps that are installed on the mobile devices of both patients and others, such as a caregiver, according to the release. The user can designate “followers” who may view their CGM data.
Data transmitted directly from the G4 Platinum System CGM receiver to the app is communicated to a Web-based storage location; from here, the app of the “follower” can download and display it.
The FDA reviewed the system through the de novo classification process, used for low- to moderate-risk medical devices new to the market and not considerably equivalent to an already legally marketed device, according to the release.
The agency classified the device as class II exempt from premarket submissions. Manufacturers seeking to market similar devices in the future would not need premarket clearance but would need to register and list their device with the FDA, along with following other relevant laws and regulations.
“Exempting devices from premarket review is part of the FDA’s effort to ensure these products provide accurate and reliable results while still encouraging the development of devices that meet the needs of people living with diabetes and their caregivers,” Gutierrez said.