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  5. Webinar - Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" - Final Guidance - 10/12/2023
  1. Workshops & Conferences (Medical Devices)

Webcast

Event Title
Webinar - Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" - Final Guidance
October 12, 2023

Date:
October 12, 2023
Time:
1:00 PM - 2:30 PM ET

Summary

On October 12, 2023, the U.S. Food and Drug Administration (FDA) will host 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 this webinar, the FDA will:

  • 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.

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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 The guidance was revised to add recommendations that were described in the draft guidance Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin.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 Details

Registration is not necessary.

Date: October 12, 2023

Time: 1:00 PM - 2:30 PM ET

Please dial in 15 minutes before the start of the call to allow time to connect.

Please click the link below to join the webinar: https://fda.zoomgov.com/j/1604587100?pwd=RFVjVjhqRmRuQm1uZmd6aDhGb0tPQT09

Passcode: fp.4Q!

Please note: Participants who join the webinar using the Zoom webinar link above should use computer audio (listen through their computer speakers and speaking through computer microphone/headset).

The dial-in information provided below is for participants who will be joining the webinar by phone only.

  • U.S. Callers Dial: 833-568-8864 (Toll Free)
    • For higher quality, dial a number based on your current location:
      • +1 669 254 5252 US (San Jose)
      • +1 646 964 1167 US (US Spanish Line)
      • +1 646 828 7666 US (New York)
      • +1 551 285 1373 US
      • +1 669 216 1590 US (San Jose)
      • +1 415 449 4000 US (US Spanish Line)
  • International Caller Dial: Please check the international numbers available
  • Webinar ID: 160 458 7100
  • Passcode: 930120

Webinar Materials

The presentation, printable slides, and transcript will be 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.

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