Why Medical Device Companies Need to Fear FDA Warning Letters

The FDA examines whether medical devices comply with the regulations of the Food, Drug, and Cosmetic Act. Two of the most common violations medical device companies are charged are adulteration [...]

Does FDA Deem My Product to be a Medical Device?

Does FDA deem your product to be a medical device, or is it just a consumer product that would not be regulated by FDA? Here are basic steps you can take to work through the puzzle.