FDA Issues Guidance Document on Use of ISO 10993-1
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 […]