Understanding FDA Standards for Blood Glucose Testing Meters

Monitoring your blood sugar levels is an important part of your Revero program, and your meter needs to take accurate readings. To guarantee reliability, glucose meters must meet certain standards set by the Food and Drug Administration (FDA). Let’s take a brief look at the standards used for meter quality.

FDA standards for blood glucose meters

The FDA regulates medical devices in the United States, including blood glucose meters. They establish performance criteria and guidelines to ensure the safety and effectiveness of these devices.

The FDA reviews and approves glucose meters before they are marketed in the US.

To gain FDA approval, glucose meters must demonstrate:

1. Accuracy: The meter must provide accurate and reliable results within a specific range established by the FDA.
2. Precision: The meter must consistently provide precise results within an acceptable margin of error.
3. Usability: The meter must be user-friendly, with clear instructions and easy-to-understand features.
4. Safety: The meter must be safe for individuals with diabetes without posing any significant risks or adverse effects.

Your iGlucose meter complies with FDA standards

The iGlucose meter provided to you by Revero meets the strict compliance and quality control standards of the Food and Drug Administration. You and your Revero health team can use the iGlucose glucose meter to make educated decisions about your health. You can feel comfortable knowing that these standards serve as a benchmark, ensuring that your glucose meter meets the stringent performance and safety requirements, ultimately promoting better diabetes management and health outcomes.