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Location: Room 202AB
Title: ISO 10993-1 Committee Draft and FDA Guidance Update: Key Biocompatibility Changes and Regulatory Status
Event Type: Discover.Engineer.Build Conference
Last year, a Committee Draft of ISO 10993-1 was submitted for review by ISO experts, reflecting the latest developments in biocompatibility evaluation. Simultaneously, the FDA introduced a new Guidance on Biocompatibility, marking significant strides in this field, particularly in light of next-gen design and emerging technologies. In this presentation, we will delve into the evolving concepts within these documents, with a keen focus on their relevance to next-gen design and emerging technologies, and provide insights into their current regulatory acceptance. Furthermore, we will address the latest comments on the draft and resolutions arising from the ISO committee meeting. Attendees will gain knowledge about:
• What new requirements, especially those pertaining to next-gen design and emerging technologies, are under discussion in the standard and FDA guidance?
• What novel concepts, particularly related to cutting-edge technologies, are currently under consideration?
• How are medical devices designed for skin contact, especially those utilizing emerging technologies, being assessed?
• What lies ahead for both of these critical documents, considering the rapid pace of innovation and technological advancement in the field?"
