Keys for the Commercialization of Medical Devices in the US
By Maria Jose Lopez Barragan, Ph.D. Markentry USA Partner and Juan Rivera-Mata, Ph. D. Markentry USA Partner Many companies plan their entry into the American market without a good understanding of the legal requirements that govern their products in the US. The FDA (Food and Drug Administration) regulates the consumption not only of drugs and food, but also of veterinary products, cosmetics, tobacco, and so-called “medical devices”.About one-fifth of what American consumers spend is, in one way or another, regulated by the FDA Under the category of medical devices there is a wide variety of products that ranges from complex devices that assist robotic surgery or even artificial organs, to objects that accompany our daily lives and whose perception can be very different from what anyone would consider a medical…