Precongress Symposium: Vascular Prostheses

Abstract

The U.S. Food and Drug Administration (FDA) believes that a performance standard for vascular graft prostheses ≥6 mm in diameter is necessary to control the risks associated with such devices. These include infection, occlusion, noncompliance, porosity issues, structural integrity, and nonbiocompatibility. In 1979 the FDA published its proposed rule to classify these grafts into Class II devices. The data supporting the need for a performance standard have come from FDA Advisory Committee Proceedings, contract safety and performance studies (1979), and the recent Vascular Graft Safety and Update Symposium (1984). Voluntary standards have been submitted by the AAMI (Association for the Advancement of Medical Instrumentation) VP‐D/84 and the ISO/DP 7198. The amendment to the Federal Food, Drug, and Cosmetic Act, known as the Medical Device Amendment of 1976, under Section 514 presents the procedure for the development of performance standards. This article describes the participation by those regulatory, manufacturing, tester, and user groups most affected by the standards and most directly involved in standards development procedures.