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Very few days go by without someone asking me to explain the differences between FDA submission types. This most

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You KNOW  your proposed deregulation of medical devices is a bad decision when even the device manufacturers ask you to

Can you explain the difference between intended use and indications for use? 🤔 The terms are NOT interchangeable, but

Choosing the right FDA pathway for your product is not easy and can be fraught with regulatory landmines. But by asking

Acceptance: The Fifth Stage of Regulatory Grief (video) Let's face it - no one likes being told what to do, and

Regulatory Depression? Blame Bad Design Controls (Video) The regulatory submission process can leave most anyone

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FDA exemptions can confuse even the most seasoned regulatory specialist, and it can be difficult to know which process