Dexcom rejects claims of unauthorized device changes in FDA warning letter

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Dexcom disputed the assertions in a Food and Drug Administration warning letter that the company implemented unauthorized modifications to its glucose sensors. 

Company spokesperson Nadia Conard stated in an email on Tuesday that no design alterations were made, which contradicts the wording in a warning letter sent 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, noting that “extensive testing” demonstrated the material met specifications.

In the warning letter, the FDA stated that Dexcom altered a component used in the resistance layer of its sensors. In a clinical study to prove the components were equivalent, Dexcom did not achieve its primary endpoint, according to the FDA. 

Dexcom also denied claims in the warning letter that the company made significant changes to its devices without submitting a premarket notification. The company informed the FDA both informally and formally through 510(k) submissions, adhering to 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 submitted 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 impact 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.