Virtual | Virtual
Event Title
Webinar – FDA’s Total Product Life Cycle Approach to In Vitro Diagnostic Products (IVDs)
October 24, 2024
- Date:
- October 24, 2024
- Time:
- 1:00 PM - 2:00 PM ET
Summary
On October 24, 2024, the U.S. Food and Drug Administration (FDA) will host a webinar for laboratory manufacturers and other interested parties to discuss the FDA’s Total Product Life Cycle (TPLC) approach to the oversight of in vitro diagnostic products (IVDs).
The FDA’s TPLC approach allows the FDA to review and monitor medical devices throughout their life cycle by taking into account all available information on safety and effectiveness.
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If you have questions that you wish to submit for possible discussion during the webinar, please email CDRHWebinars@fda.hhs.gov. All questions must be received by September 23, 2024, to be considered for the discussion. Questions will be not be taken during the live webinar.
Webinar Details
Registration is not necessary.
Date: October 24, 2024
Time: 1:00 PM – 2:00 PM
Please dial in 15 minutes before the start of the call to allow time to connect.
We anticipate high attendance for this webinar and there is limited capacity. We encourage you to join early. However, due to the limited capacity we intend to post a recording and transcript as soon as possible following the webinar.
Meeting Link: https://fda.zoomgov.com/j/1616994355?pwd=cWZhS2RucTU4ZUNLbGF5ZFN5Wlo5dz09
Passcode: %KeTf9
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)
- +1 669 216 1590 US (San Jose)
- +1 415 449 4000 US (US Spanish Line)
- +1 551 285 1373 US (New Jersey)
- For higher quality, dial a number based on your current location:
- International Callers Dial: Please check the international numbers available
- Webinar ID: 161 699 4355
- Passcode: 066992
Webinar Materials
The presentation, printable slides, and transcript will be available on this webpage and at CDRH Learn under "In Vitro Diagnostics."
If you have questions about this 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.