Look Before You Leap – Early Determination of Product Classification and Regulatory Pathway for FDA-Regulated Products

Originally published in Healthcare Michigan, Volume 41,  No. 4 The Food and Drug Administration (FDA) regulates foods and beverages, drugs and medical devices, biologics, dietary supplements, tobacco products, veterinary products, and cosmetics. Although these various product categories may appear to be clearly cut, the fact of the matter is that a product can very easily cross …