This is in lieu of biocompatibility testing in accordance with the blue book memorandum. Testing and evaluation strategies for the biological. Use the blue book memo g95 1 use of international standard. Fda has published for comment a new draft guidance on application of iso 10993. Webinar final guidance on use of international standard. Standard is010993, biological evaluation of medical devices part1. This page contains information about the webinar final guidance on use of international standard iso 109931, biological evaluation of medical devices part 1. This guidance was written prior to the february 27, 1997 implementation of fdas good guidance practices, ggps. As of september 14, 2016, this document supersedes blue book memorandum. A sensible approach to biocompatibility testing mddi online.
Submit either electronic or written comments on this guidance at any time. Required biocompatibility training and toxicology profiles for. Use of international standard iso 109931, biological. Fda finalizes biocompatibility guidance for medical devices. In may 1995, fda issued blue book memorandum g951, use of international standard iso10993, biological evaluation of medical devices part 1. Evaluation and testing, blue book memorandum g951, rockville. Fda then issued blue book memorandum g951 use of international standard iso10993. Originally published mddi august 2003 regulatory outlook.
Regulatory guidelines for biocompatibility safety testing. This memo was a huge step toward international harmonization of device biocompatibility testing, although there are still some significant differences between fda and european. Specific tests that can be used to satisfy these requirements are then provided in iso 109935, which covers cytotoxicity, and iso 10993. Use of international standard iso10993, biological evaluation of medical devices, part 1. Use the blue book memo g95 1 use of international standard iso 10993 and from bioe 5250 at northeastern university. This guidance is intended to replace the 1995 blue book memo g951. Collamatrix stated in the fda blue book memorandum g951 and iso 10993.