Scientific Publications by FDA Staff

Int J Toxicol 1988 Jul-Aug;7(4):499-503

Uses of Toxicology Data for Medical Devices: The FDA Perspective

West DL

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.