What Are the FDA and EU/ISO Requirements for Biocompatibility Testing?
• The best starting point for understanding biocompatibility requirements is ISO Standard 10993, Biological Evaluation of Medical Devices. Part 1 of the standard is the Guidance on Selection of Tests, Part 2 covers animal welfare requirements, and Parts 3 through 19 are guidelines for specific test procedures or other testing-related issues (click here for a list of the individual sections of ISO 10993). Testing strategies that comply with the ISO 10993 family of documents are acceptable in Europe and Asia. In 1995, FDA issued a Blue Book Memorandum G95-1, which replaced the tripartite Guidance (the previous biocompatibility testing standard). FDA has substantially adopted the ISO guideline, although in some areas FDA’s testing requirements go beyond those of ISO. The specific ISO test procedures vary slightly from the USP procedures historically used for FDA submissions. The ISO procedures tend to be more stringent, so companies planning to register their product in both Europe and th
