Medical Device FDA U.S. Agent IntroductionAny foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device imported into the United States must id...

Medical Device Facility Registration Introduction Owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of medical d...

FDA 510(k) IntroductionEach person who wants to market in the U.S., a Class I, II, and III device intended for human use, for which a Premarket Approval (PMA) is not required, must submit a 510(k) to ...