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  • dfn3 replied to the topic Precision and Accuracy in the forum Regulatory Basics for Medical Devices 6 years, 11 months ago

    I agree that accuracy and precision are so important to the FDA. They cannot have a drug or device not pass those regulations because they will be used for the general population. If they do not follow the the FDA regulations it could be harmful to the general public. Ofcourse there will never be a device or drug that is perfect but they want to lessen the complications as much as they can. They need to be as precise as they can when it comes to the devices because usually the device is to be used without the user having to do much. So also the accuracy has to be at the best it can be so the device can be used the best possible way. Same for drugs if the drugs does not follow the FDA regulations it could be potentially harmful for the public.