• Summary
• Background
• Webinar Materials

Summary

On October 12, 2023, the U.S. Food and Drug Administration (FDA) held a webinar for industry and other interested stakeholders to discuss 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."

During the webinar, the FDA:

• Provided 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
• Explained related changes made to the electronic Submission Template and Resource (eSTAR) form
• Answered questions about the final guidance and eSTAR changes.

Background

The final guidance is intended to assist industry and other stakeholders in preparing Premarket Applications (PMAs), Humanitarian Device Exceptions (HDEs), Investigational Device Exemption (IDE) Applications, Premarket Notifications (510(k)s), and De Novo requests for medical devices that come into direct contact or indirect contact with the human body. The guidance was revised to add recommendations that were described in the draft guidance Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin. The final guidance reflects the FDA's current thinking about the type of biocompatibility information that should be provided in a medical device premarket submission for certain devices in contact with intact skin (see Attachment G of the guidance).

Webinar Materials

The presentation, printable slides, and transcript are available at CDRH Learn under "Specialty Technical Topics," sub-section "Biocompatibility."

If you have questions about this guidance or webinar, please contact CDRH's Division of Industry and Consumer Education (DICE) at dice@fda.hhs.gov, 1-800-638-2041, or 301-796-7100.