FDA Clearance
Definition
The regulatory approval pathway for CGM devices in the United States, typically through the FDA's 510(k) process, which requires the manufacturer to demonstrate that a new device is substantially equivalent to an existing legally marketed device. FDA clearance evaluates safety and accuracy data — including MARD performance in clinical trials — before a CGM can be sold in the US. As of 2026, every CGM sold in the United States from Dexcom, Abbott, and Senseonics has received FDA clearance, and the FDA has created a new regulatory pathway specifically for over-the-counter CGMs.
Why “FDA Clearance” Matters for Glucose Monitoring
Understanding fda clearance is essential for anyone using or evaluating a continuous glucose monitor. This concept directly affects how CGM devices are designed, how glucose data is interpreted, and how clinical decisions about blood sugar management are made. Regulatory classifications determine which CGMs you can buy without a prescription, which devices can be used for insulin dosing, and how insurance coverage is determined.
This term is particularly relevant to 4 CGM products in our database. Understanding fda clearance helps you compare devices more effectively and choose the right continuous glucose monitor for your specific needs.
Related Terms
A continuous glucose monitor that can be purchased directly by consumers without a prescription, representing a new regulatory category established by the FDA in 2024.
A regulatory classification that determines whether a CGM can be used as the sole basis for treatment decisions.
Mean Absolute Relative Difference, the gold standard metric used to evaluate CGM sensor accuracy.