The FDA and regulatory issues in graft development.
Regulatory issues in graft development range from mundane to complex because of the extensive diversity in graft technology. This article, describes the regulatory differentiation between types of grafts, incorporating a description of the system for classifying devices by the Food and Drug Administration (FDA). Information relating to the need for and the regulation of clinical investigations of grafts is included. This discussion includes a description of the current work by the International Organization of Standards on endovascular devices. Finally, a contrast between clinical studies sponsored by manufacturers and individual clinical investigators is provided.
Abel
D
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Office of Device Evaluation, US Food and Drug Administration, Rockville, MD 20850, USA.
Shulman
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D001807:Blood Vessel Prosthesis / Q000009:adverse effects / Q000145:classification / Q000592:standards*; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration