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 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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