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  • ap499 replied to the topic FDA rules too strict? in the forum Regulatory Basics for Medical Devices 6 years, 11 months ago

    I personally feel that the FDA’s strict rules are essential when it comes to new devices or products in order to protect the public from the possible bad outcome. It is their central goal to protect the public health and safety. The FDA was organized by the U.S. as the regulatory department for all human drugs, animal drugs, medical devices, equipment that emits radiation, face, and body cosmetics, and last but not the least food. Due to these strict rules, they tend to have a long and detailed process that needs to be followed in order to get a device or a drug out in the market. It has its own few benefits, it verifies multiple times with their own various clinical trials until the results are safe and no harm to a human being when used.