US breaks away from tripartite agreement on biocompatibility
This article was originally published in Clinica
Executive Summary
The US FDA is to introduce new guidance on biocompatibility standards for medical devices from July 1st, according to a May 1st memorandum from the Department of Health and Human Services. The guidance is based on Part-1 of the ISO standard, Biological Evaluation of Medical Devices, and replaces the Tripartite Biocompatibility Guidance, G87-1, issued in 1986 by the US, Canada and the UK and used by reviewers and manufacturers alike.