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ap499 replied to the topic Precision and Accuracy in the forum Regulatory Basics for Medical Devices 6 years, 11 months ago
In the medical field, both accuracy and precision are essential in order to ensure that results are valid. When one is not able to achieve either accuracy or precision requirements then a device is bound to fail tests or further calibration. These are among many reasons when a device or any drug are recalled or discontinued. The U.S. Food and Drug Administration has set a high standard regarding accuracy and precision to ensure that calibrated equipment meets certain requirements. Some errors for not meeting this accuracy and precision limits are a personal human error, method error or instrumental error. When these limits are not met, then they are re-evaluated and recalibrated to bring the potential results.