Dexcom’s FDA warning letter reveals unauthorized changes to sensors

Dexcom made a significant design change to a component used in its sensors and did not adequately validate the change, according to the warning letter.

Mar 26, 2025 - 16:44
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Dexcom’s FDA warning letter reveals unauthorized changes to sensors

Dexcom made a significant design change to a component used in its sensors and did not adequately validate the change, according to the warning letter.