The FDA has implemented a challenging new standard that affects all medical device manufacturers in the United States. This article provides an overview of the foundations and evolution of medical device regulation, leading up to a discussion of the new philosophy encompassed by the 3rd edition of the International Electrotechnical Commission’s general standard for assessing the safety of medical devices, IEC 60601-1:2005. Understanding the implications of these new regulations enables manufacturers to adjust their business plans and adapt accordingly.