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  4. Investigational Use Requirements for In Vitro Diagnostic Products (IVDs), including Laboratory Developed Tests (LDTs) Under 21 CFR 812 - 02/25/2025
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Webcast | Virtual

Event Title
Investigational Use Requirements for In Vitro Diagnostic Products (IVDs), including Laboratory Developed Tests (LDTs) Under 21 CFR 812
February 25, 2025

Date:
February 25, 2025
Time:
2:00 p.m. - 3:00 p.m. ET

Summary

On February 25, 2025, the U.S. Food and Drug Administration (FDA) will host a webinar for  manufacturers and other interested parties to provide information on investigational use requirements for in vitro diagnostic products (IVDs), including laboratory developed tests (LDTs). This webinar will describe the Investigational Device Exemptions (IDE) Regulation (21 CFR Part 812) and the regulatory requirements it contains for the study of investigational devices, and FDA’s typical review process for an IDE application.

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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 January 24, 2025, to be considered for the discussion. Questions will be not be taken during the live webinar.

Webinar Details

Registration is not necessary.

Date: February 25, 2025

Time: 2:00 PM – 3:00 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.

Join the meeting: https://fda.zoomgov.com/j/1613792690?pwd=GMjAawgvap4dnMaYhnLvMiRFefN93G.1

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) o 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)
  • International Callers Dial: Please check the international numbers available
  • Webinar ID: 161 379 2690
  • Passcode: 923204

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.

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