All you need to know about a Premarket Approval (PMA) Submission — Route to the US Market for Class III medical devices
The Federal Food Drug and Cosmetic (FD&C) Act established three regulatory classes for medical devices – Class I, Class II, and Class III, in order to ensure that the devices are safe and effective for public health. To permit only the safest and most effective medical devices into the market, the FDA has three levels…
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