Update to FDA Guidance Use of International Standard ISO 10993-1 and Biocompatibility of Devices in Contact with Intact Skin

By: Claus Soendergaard, Senior Manager of Biocompatibility

On September 8th 2023, FDA issued an updated version of their primary biocompatibility guidance, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". This marks the first update to the guidance since 2020, making it important to explore the revisions and their potential implications for future biocompatibility assessments.

While the updated guidance provides additional clarity on FDA’s thinking on biocompatibility and offers some much-anticipated opportunity to lessen the testing burden for certain device with intact skin contact, biocompatibility still commands significant time and resource commitments throughout the medical device life cycle. That is why you can rely on MCRA’s team of expert regulatory and biocompatibility specialists to help you navigate the intricacies of this updated guidance and your biocompatibility needs in general to expedite your product's market entry and patient access.