FDA issued a new draft guidance document on biocompatibility on Tuesday April 23, entitled Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing. It is intended to replace the ODE General Program Memorandum #G95-1. G95-1 was issued in 1995 in the span of 18 years a lot has changed regarding FDA’s view on biocompatibility.
[fa icon="clock-o"] 4/25/13 7:11 AM [fa icon="user"] Ryan Kasun [fa icon="folder-open'] Biocompatibility, Medical Devices, premarket submissions, G95-1, standard iso, ISO 10993-1, FDA, draft guidance document, Guidance Document, biological evaluation, iso 10993, fda clearance
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