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BijinV replied to the topic Precision and Accuracy in the forum Regulatory Basics for Medical Devices 7 years, 6 months ago
The importance of accuracy and precision when it comes to the FDA stems from concerns over safety. If a device or drug is not accurate or precise, there is no way the FDA can allow that level of variability and unknown be used by the general population. Additionally, precision and accuracy are needed if a new device or drug is to be used over a well established treatment methodology. That is not to say that this will eliminate complications or side effects, but more so to establish the consistency of these unwanted effects as much as the desired effects.