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gsharma replied to the topic Precision and Accuracy in the forum Regulatory Basics for Medical Devices 6 years, 6 months ago
It is very important that the medical devices actually do what it says it will do. This is one of the requirement in the medical device amendments of 1976 that the medical device must be safe, effective and labeled properly. The device should not kill people, it must do what it’s supposed to and the device can’t have false information. FDA takes this very seriously to prevent any health risk associated with the device and they inspects, evaluate and regulates all necessary documentation for medical device companies.