The long-awaited part 23 of ISO 10993, the series of standards governing Biological Evaluation of Medical Devices, was published in January 2021. It was the first to introduce validated methods for in-vitro irritation tests. This article reviews the latest developments and identifies the cases in which manufacturers can avoid animal experiments.
The agency recently released a guidance document that gives device manufacturers an optional pathway to make certain modifications to their device.
Procedures for design validation must address risk analysis where appropriate.
Fewer resources and more requirements are hindering the process.