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hzy2 replied to the topic FDA rules too strict? in the forum Regulatory Basics for Medical Devices 6 years, 6 months ago
It might be a lot of work on the companies’ end because of all the regulatory steps they need to follow to bring a product to the market. It seems to be tedious work but these products are used on or implanted into humans and in order to protect their safety, FDA has to be strict about its rules and regulations. It does slow down the process of products coming to the market but I think it is much better to bring something out late with a lot of caution than to bring something out without proper testing and documents that will harm people and possibly result in a lot of lawsuits for both the companies and the FDA.