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[FDA News] October 12th Webinar_Use of ISO 10993-1 (Biocompatibility) Final Guidance


fda biocompatibility final guidance iso 10993-1

The U.S. Food and Drug Administration (FDA) will host a webinar to share information and answer questions about the final guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process."


· Date: October 12, 2023

· Time: 1:00 to 2:30 p.m. (ET)



Topics to be covered in the FDA webinar:


  • Provide an overview of the new Attachment G, which describes a new policy for certain devices that contact intact skin including:

- the types of devices, components, and materials included in the policy

- recommendations for what information and labeling should be provided in premarket submissions

  • Explain related changes made to the electronic Submission Template and Resource (eSTAR) form

  • Answer questions about the final guidance and eSTAR changes.


Please refer to the following for details on how to join the webinar and for more information.





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