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The food, drug and Cosmetic Act (FDC) were started in the year 1938, and it also allowed that the medical products that...

For companies who are not prepared to submit a 510k regulatory clearance, then the procedure can be painful for you. We have...

Did you know? You cross with the regulatory affairs industry almost daily, but don’t observe it. Each food product, beverage, or a...

The design given to a medical device should be able to add some value to the end-user and should also capture a...