FDA's updated biocompatibility guidance is here

Medical devices and IVD regulatory expert with a global perspective

June 2016

FDA’s updated biocompatibility guidance is here

< 1 min reading time

FDA’s New Biocompatibility Guidance is here. It’s a detailed, lengthy guidance, with a strong emphasis on risk management grounded in a thorough knowledge of device materials toxicology. This is a very different guidance from the old G95-1.

FDA Biocompatibility – New Risk Based Guidance on ISO 10993

The long awaited refresh of US FDA’s biocompatibility guidance has finally arrived. This is a quantum leap from the old G95-1 Blue Book Memo. The guidance is firmly rooted in a risk based approach, and provides detailed advice on all aspects…

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