FDA ADOPTING ISO BIOCOMPATIBILITY TESTING STANDARD BY THE END OF THE YEAR, PROVIDING MORE FLEXIBLE DEVICE TESTING REQUIREMENTS THAN TRIPARTITE GUIDANCE
This article was originally published in The Gray Sheet
Executive Summary
FDA will replace the Tripartite Biocompatibility Guidance with an International Organization for Standardization document (ISO 10993, part 1) as its standard for premarket testing of devices for biocompatibility.