OR WAIT null SECS
Under Commissioner Scott Gottlieb, MD, the agency has made a concerted effort to move towards a less cumbersome, technology-friendly, risk-based approach.
The FDA today announced the approval of the “first fully interoperable continuous glucose monitoring (iCGM) system,” thus opening a new review pathway for similar devices.
The Dexcom G6 is a quarter-sized patch device that sends glucose levels to a compatible interface, like a mobile phone. It sends an alarm when blood sugar trends too high or low. The patch must be replaced every 10 days.
The agency’s decision was based on 2 clinical trials of the device, including 324 adults and pediatric patients with diabetes. During the trials, no serious adverse events were reported, and the patients underwent multiple clinic visits in the 10-day study period to compare blood glucose measurements.
Donald St. Pierre, the acting director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said that the device’s interoperable capability “gives patients the flexibility to tailor their diabetes management tools to best meet personal preferences.”
Other continuous glucose monitoring systems have been evaluated through the FDA’s class III medical device pathway—for high risk devices—but according to the agency, the Dexcom’s interoperability with other devices places it in a lower tier.
“The FDA recognized this as an opportunity to reduce the regulatory burden for this type of device by establishing criteria that would classify these as ‘moderate risk’ class II medical devices with special controls,” according to an official statement. “Future iCGMs that meet the special controls criteria can go through a more streamlined premarket review known as 510(k) clearance.”
Under Commissioner Scott Gottlieb, MD, the FDA has made a concerted effort to move towards a less cumbersome, technology-friendly, risk-based approach. In the fall, it issued a series of guidance documents around 510(k) premarket notifications and “breakthrough devices” as designated by the 21st Century Cures Act.
The 510(k) clearance for Dexcom was the second issued by the FDA for a glucose monitor this week. On Monday, Israel’s DarioHealth announced that it had received the designation for an updated version of its Blood Glucose Monitoring System. The company had to release a new system, which syncs with smartphones through the standard 3.5mm headphone jack, when Apple decided to remove that input from its new iPhone models.