The Tripartite Biocompatibility Guidance for Medical Devices is reviewed, and the toxicity data needed by the Food and Drug Administration to evaluate medical devices is discussed. Some of the types of data required, the rationale for their need, and the legal requirements and processes are emphasized.
References
1.
1. Toxicology Subgroup, Tripartite Subcommittee On Medical Devices. (1986). Tripartite Biocompatibility Guidance for Medical Devices, Washington, DC: U.S. Department of Health and Human Services.
2.
2. American Society For Testing And Materials (Astm). Committee F-4 on Medical and Surgical Materials and Devices, Astm Committee on Standards. (1982). Standard Practice for Selecting Genetic Biological Test Methods for Materials and Devices. F 748–82, Philadelphia, Pa.
