White Paper

FDA Recognition of ISO 10993-1: 2018

ISO 10993-1 was revised in August of 2018 and included a big expansion on the risk based development and safety evaluation of medical devices.  There were not a lot of big changes, but there were a few including an expansion of evaluation requirements in Table A.1 in Annex A, noting reusable devices need to be evaluated at the end of their validated reprocessing life cycle and the introduction of transitory and non-contacting devices and their material components.