FDA Clears First Over-the-Counter Continuous Glucose Monitor for Children
The FDA cleared the Dexcom Stelo Glucose Biosensor System, making it the first over-the-counter integrated continuous glucose monitor (iCGM) indicated for use in children two years of age and older who do not use insulin.
Dexcom Inc., manufacturers of continuous glucose monitoring systems, and regulatory professionals managing non-prescription medical device transitions.
This clearance represents a significant expansion of the OTC CGM market into the pediatric demographic. It indicates a regulatory pathway for iCGM devices to be marketed directly to consumers for non-insulin-using populations, which may necessitate more robust human factors testing and simplified labeling suitable for non-professional users. The inclusion of the pediatric population suggests the FDA has reached a level of confidence in the safety and accuracy of these systems for younger age groups in a non-clinical setting.
Regulatory teams should review existing CGM labeling and 510(k) strategies to assess the feasibility of OTC expansion for non-insulin using populations. Quality systems must ensure that user manuals and interface designs are validated for pediatric use and layperson interpretation without healthcare provider intervention.
The U.S. Food and Drug Administration today cleared for marketing the first over-the-counter (OTC) continuous glucose monitor (CGM) for children, Dexcom Inc.’s Stelo Glucose Biosensor System, an integrated CGM (iCGM) indicated for people two years of age and older who do not use insulin.
Open in openFDA / FDA.gov