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  • andria93 replied to the topic FDA rules too strict? in the forum Regulatory Basics for Medical Devices 6 years, 8 months ago

    I don’t work directly with process involve working with FDA, But I’ve heard how long it takes for FDA to process. One of the most concern when we work with project required FDA approval for part replacement, the company will try to avoid because of testing and requalification could take months if not a year. But, on the other hand, FDA tries to secure human health and make sure it is okay to roll out the product. However, we still see mistakes and failure and recalls, So we can imagine if FDA is leaner, we will face more of these problems I think. In my opinion, FDA should be faster either but having more resources dedicated to working on a project or utilizing tools to make processes faster, but not changing the rules. We need an organization such as FDA because some companies only care about revenue with exceptions to work ethics and that when we appreciate FDA regulations.