Safety and Performance of Angiographic and Lymphographic Injectors

摘要

Under the Medical Device Amendments of 1976, the Food and Drug Administration (FDA) through its Bureau of Medical Devices (BMD) is charged with assuring the safety and efficacy of medical devices and in vitro diagnostic products. Devices that have been placed in class II by the various device classification panels require a standard to be either adopted or developed. This document concerns itself with angiographic and lymphographic injectors exclusively. Its purpose is to provide a basic knowledge of these devices including appropriate terminology, clinical applications, delineation of manufacturers, and a risk/hazard assessment of their usage. This document can be considered to be a first step in the development of a standard. The approach applied to produce this document includes the following: a literature search and analysis; a review of the device manufacturer's marketing literature, operation manuals, and service manuals; and interviews with users of these devices.