Section 514 of the Food, Drug, and Cosmetic Act requires performance standards to assure reasonable safety and effectiveness. Although the procedures appear to be complex and lengthy, they are comparable to those established by national and international standards organizations. Persons most directly affected by the standard may participate in both the performance standard development and the establishment of a final regulation on the performance standard. As a part of due process, those most affected have the opportunity to request a review of any matter by an advisory committee of experts. A key element in the performance standard development procedure is the establishment of a statement of the risks associated with the use of the device and intended to be controlled by a performance standard. For vascular graft prosthesis with diameters of 6 mm and greater, the establishment of the device risks and methods of control will be the basis from which the development of a performance standard can proceed. The objective is to select a set of risks and methods of control so that the standards development procedure is manageable and results in an effective performance standard.