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tilak replied to the topic FDA rules too strict? in the forum Regulatory Basics for Medical Devices 7 years, 6 months ago
The processes laid down by the FDA maybe lengthy and tedious but they are not too strict. Without the FDA, there aren’t many other government organizations or groups that can be as effective in delivering rulings, and regulations over the vast amounts of medical devices, drugs and other consumer products that are released into the market every year. The FDA has drastically improved the safety of medical devices and its practices in the country. Many other countries lack such regulation, and as a result their medical care is much more risky and dangerous. The amount of testing the FDA requires by medical device companies helps to prove the accuracy and precision of their products.