September 8, 2020 – The FDA issued a guidance document on September 4, 2020, on Use of International Standard ISO 10993-1, “Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process”. This document is available on the FDA’s website here.
This guidance document, which supersedes the 2016 version of the document of the same name, covers the FDA’s interpretation of the ISO 10993-1 standard, which was updated in 2018, covering biological risk assessment and biocompatibility testing.
A copy of the Biological Risk Assessment matrix from ISO 10993-1:2018 is available here, on our website.
For questions or more information on the interpretation of the standard for testing of your medical device, please contact us for more information on our testing or consulting offerings.