Medical Device Link -- Suddenly you find yourself responsible for having a medical device evaluated for biocompatibility. What does this mean and how do you go about it? As a start, perhaps you search the FDA Web site for the topic of biocompatibility testing. You may find yourself on pages discussing the Blue Book Memorandum No. G95-1 titled, “Use of International Standard ISO 10993,” under Part One of “Biological Evaluation of Medical Devices.” Realizing that Blue Book Memorandum No. G95-1 is deferring you to something called ISO 10993, you may try to get your hands on that document. However, that costs time and money, and the document looks the same as the one on the FDA Web site.
