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

    Yes the FDA is too strict, but when it comes to regulating a devise that affects a human and their life, the FDA needs to be really strict. This causes them to be slow, really slow. But I don’t think that’s bad. It’s better to be slow and sure than to be fast and allow a chance of failure (which could potentially cause death). I understand the argument that FDA’s rigid applications and regulating procedures might drastically slow down future innovations, but in this day and age, there are usually many substitutes to keep the patient under treatment until those future innovations are justified. If the innovation is completely novel and could save lives like no other device, there is the Humanitarian Device exemption (HDE) under the FDA that allows these kind of devices to be used in 4000 or less patients. Due to these reasons I think it is good that the FDA is strict and should continue being so for the health and safety of the public.