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  • msc52njit-edu replied to the topic Precision and Accuracy in the forum Regulatory Basics for Medical Devices 6 years, 10 months ago

    In the medical device department I think that accuracy is making sure the device will perform the necessary actions that it is set out to do, and precision is making sure that the test results you get are consistent with each other and that you are not getting any extreme results or findings in your research. Accuracy is important because if a device or drug does not perform the way it is intended to, then it is useless and will not be bought on the market. Precision will convince the FDA and the user that the drug will most certainly always work, that is reliable to use, and that it will not cause any risky side effects that are not anticipated for. They are so important to the FDA because if you can not prove that your device actually meets the description set out for it then it will not be approved, as the results do not meet the intended use. Precision is important because the FDA wants to see that the device will always work no matter who it is used on or implanted in. If the device shows it will only work half of the time then the FDA will not accept it because of the risk of unanticipated side effects. Pre-Clinical and Clinical trials show that a device is accurate in its results and that the results are precise and consistently around the same desired results.