Updated FDA guidance document for evaluating the biological safety of medical devices

Based on the update of the international standard ISO 10993-1 standard in 2018, the FDA has now revised its associated guidance document. The new version of the Use of International Standard ISO 10993-1, „Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process“ replaces the version from June 16, 2016 (G95-1). The purpose of this guideline is to provide further clarification and updated information on the use of the ISO 10993-1 „Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing as Part of a Risk Management Process“ to support submissions to the FDA. In addition, the guidance document also incorporates several new considerations, including the use of risk-based approaches to determine if biocompatibility testing is needed, chemical assessment recommendations, and recommendations for biocompatibility test article preparation for devices with submicron or nanotechnology components and for devices made from in situ polymerizing and/or absorbable materials, which were not previously discussed in G95-1. The updated guidance document can be downloaded here.