The passage of the Medical Device Amendements to the Food Drug and Cosmetic Act on May 28, 1976 placed a huge number of products under the regulatory authority of the Food and Drug Administration (FDA). This increased responsibility took many forms related to device evaluation which will be discussed in this paper. In order to institute control of all devices it was necessary to “take inventory” of what was on the market. This was accomplished by establishing device panels for the various medical specialties composed of experts familiar with the devices areas who compiled a generic device list for their specialty areas. Each device was classified according to its hazard potential and existing data related to safety and effectiveness.