FDA guidance on ISO 10993 and biological evaluation of medical devices

The United States Food and Drug Administration (FDA) has updated their guidance document for industry on biological evaluation of medical devices according to the ISO 10993-1 standard. The guidance replaces an almost 20-year-old guidance and incorporates several new considerations, including the use of risk-based approaches to determine if biocompatibility testing is needed. Recommendations for submicron, nano and in situ materials The guidance also includes chemical assessment recommendations, and recommendations for biocompatibility test preparations for devices with submicron or nanotechnology components and for devices made from in situ polymerizing and/or absorbable materials. Concerning the risk-based approach to biocompatibility, it is recommended that risk assessments should include not only the finished material but also device materials, processing parameters and manufacturing methods. Furthermore, when conducting risk assessments manufacturers should thoroughly screen for any available risk information and data to avoid unnecessary testing. Further information is available at: Use of International Standard ISO 10993-1, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process

DHI Chemicals and Regulatory Toxicology Newsletter, November 2016 ;http://www.dhigroup.com ;