In September 2023, the FDA released a new revision to its guidance document on the use of ISO 10993-1, which focuses on the evaluation and testing of medical devices within a risk management process. The first question to ask when a new revision is released is, “What changed?” Once that question is answered, a follow up question is, “How does that impact my device and/or submission?”
This 60-minute Webinar will review the changes to the FDA’s guidance document - including a look at the information provided in the FDA’s explanatory webinar given in October 2023 - as well as how to assess the revision’s impact on different situations. Speakers also will review some of the unchanged information to highlight lessons learned on the practical application of the guidance document.
Topics will include:
• Changes found in the new revision of the FDA guidance document
• How to assess the impact to individual situations
• Lessons learned through practical application of the document