Ahead of his presentation at Extractables & Leachables USA 2017, Toxikon have shared a white paper on 'FDA finalizes guidance on medical device safety evaluation'. The white paper covers the finalization of the FDA's guidelines, and what device manufacturers should be doing.
Regarded as a game-changer in biological safety evaluation, the FDA's finalized guideline, Use of International Standard ISO 10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and testing within a risk management process', is a significant milestone and a good opportunity to reflect on how it is impacting the biological safety evaluation of medical devices. Toxikon's white paper covers what the guideline means for device manufacturers and what they should be doing.
You can download your free copy of the white paper below.
Toxikon will be presenting as part of the Biocompatibility and safety evaluation session at Extractables & Leachables USA 2017 this May. You can view the full programme here.