G95 blue book memorandum g95 1

Use of international standard iso 109931, biological evaluation of. Required biocompatibility training and toxicology profiles for. In may 1995, fda issued blue book memorandum g95 1, use of international standard iso10993, biological evaluation of medical devices part 1. Evaluation and testing, blue book memorandum g951, rockville. The ode guidance memoranda, affectionately referred to as blue book memos, clarify these guidelines and will be added to this list as they become available. Fda finalizes biocompatibility guidance for medical devices. Regulatory guidelines for biocompatibility safety testing. Evaluation and testing, dated may 1, 1995 starting on september 14, 2016. Fda biocompatibility new risk based guidance on iso. This is a quantum leap from the old g951 blue book memo. Timeline delay allows industry and fda time to implement concepts in the document.