This guidebook provides essential information for anyone who needs to understand and implement the new U.S. Food and Drug Administration (FDA) law for medical devices and international quality system requirements. It is organized into easy-to-use tabbed sections which follow the FDA regulation breakdown. Icons are used to quickly establish the difference between the FDA law and the ANSI/ISO/ASQC Q9001 Standard, as well as provide quick references to the FDA guidance and the Global Harmonization Task Force (GHTF) guidance. Published by ASQ Quality Press.