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

    The FDA has to be very strict to protect public health by regulations to oversee food, drugs, cosmetics and medical devices. It is true that lenient FDA regulations could increase innovation in technologies to create improved drugs and medical devices however that does not guarantee the proof of safety from extensive research and clinical trials. With the currently FDA regulations, a prescription drug approval requires companies to prove its safety and efficiency with years of research and clinical trial data. FDA takes the responsibility to regulate an industry, protecting consumers from potential health risk. Without strict regulations FDA might not be able to effectively protect consumers.