Dexcom pushed back on claims in a Food and Drug Administration warning letter that the company made unauthorized changes to its glucose sensors.
Company spokesperson Nadia Conard wrote in an email Tuesday that no design changes were made, contrasting with language sent in a warning letter to the company earlier this month.
“Dexcom qualified a second source for one of its raw materials, developed since 2021, to ensure an uninterrupted supply to customers,” Conard wrote, adding that “extensive testing” showed the material met specifications.
In the warning letter, the FDA wrote that Dexcom made a change to a component used in the resistance layer of its sensors. In a clinical study to demonstrate the components were equivalent, Dexcom did not meet its primary endpoint, the FDA said.
Dexcom also rejected claims in the warning letter that the company made major changes to its devices without submitting a premarket notification. The company notified the FDA both informally and formally through 510(k) submissions, following the guidelines for non-significant changes, Conard said.
“We believe this information was disclosed responsibly and transparently and were surprised by the reference in the Warning Letter about lack of clearance,” Conard wrote. “We understand the FDA's concerns and are committed to resolving this issue promptly.”
Dexcom has filed an application with the FDA for a 15-day version of its G7 continuous glucose monitor. The company does not believe the warning letter will affect the FDA’s review of the device.
An FDA spokesperson wrote in an emailed statement that the agency does not discuss possible or ongoing investigations, compliance matters or enforcement activities, except with the company involved.
