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  4. Webinar - In Vitro Diagnostic Products (IVDs) - MDR Requirements, Correction and Removal Reporting Requirements, and Quality System Complaint Requirements - 08/22/2024
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Webcast | Virtual

Event Title
Webinar - In Vitro Diagnostic Products (IVDs) - MDR Requirements, Correction and Removal Reporting Requirements, and Quality System Complaint Requirements
August 22, 2024

Date:
August 22, 2024
Time:
1:00 PM - 2:30 PM ET

Summary

On May 6, 2024, the FDA issued a final rule amending the FDA's regulations to make explicit that IVDs are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act) including when the manufacturer of the IVD is a laboratory. Along with this amendment, the FDA outlined a policy to phase out, over the course of four years, its general enforcement discretion approach to LDTs.

On August 22, 2024, the U.S. Food and Drug Administration (FDA) will host a webinar for laboratory manufacturers and other interested stakeholders to discuss how to comply with medical device reporting (MDR) requirements, correction and removal reporting requirements, and quality system (QS) requirements regarding complaint files beginning May 6, 2025 (Stage 1 of the phaseout policy).

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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 July 22, 2024, to be considered for the discussion. Questions will be not be taken during the live webinar.

Webinar Details

Registration is not necessary.

Date: August 22, 2024

Time: 1:00 PM – 2:30 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.

Please use the following link to join the webinar: https://fda.zoomgov.com/j/1616994355?pwd=cWZhS2RucTU4ZUNLbGF5ZFN5Wlo5dz09

Passcode: %KeTf9

Please note: Participants who join the webinar using the Zoom webinar link 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)
  • 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.

 
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