ABSTRACT
The Office of Device Evaluation (ODE) of the Food and Drug Administration (FDA) announced the replacement of Tripartite Biocompatibility Guidance, dated April 24, 1987, with ISO 10993, Part 1—Biological Evaluation of Medical Devices: Evaluation and Testing, including an FDA-modified matrix that designates the type of testing needed for various medical devices. The guidance became effective for all submissions received after July 1, 1995. The flow diagram and matrix are included on pages 186 and 187.
