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  4. Webinar - Enforcement Policies for Certain In Vitro Diagnostic Devices - Draft Guidances - 06/05/2024
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Webcast | Virtual

Event Title
Webinar - Enforcement Policies for Certain In Vitro Diagnostic Devices - Draft Guidances
June 5, 2024

Date:
June 5, 2024
Time:
1:00 PM - 2:00 PM ET

Summary

On June 5, 2024, the U.S. Food and Drug Administration (FDA) will host a webinar to provide an overview of two draft guidances:

During the webinar, the FDA will:

  • Review the scope and key elements of each draft guidance.
  • Provide responses to previously submitted questions.

If you have questions about these draft guidances that you wish to submit for possible discussion during the webinar, please email CDRHWebinars@fda.hhs.gov. All questions must be received by May 24, 2024, to be considered for the discussion. Questions will not be taken during the live webinar.

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Background

The draft guidance, Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration under Section 564, when finalized, will describe the FDA's enforcement policy for certain laboratory manufacturers offering certain unauthorized in vitro diagnostic devices (IVDs) for immediate response to chemical, biological, radiological, or nuclear (CBRN) agents in the absence of a declaration applicable to IVDs under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Submit comments under docket number FDA-2024-D-0083 at www.regulations.gov by July 5, 2024, to ensure the FDA considers comments on this draft guidance before it begins work on the final version of the guidance.

The draft guidance, Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency, when finalized, will describe the factors that FDA intends to consider in determining whether to issue an enforcement policy regarding test manufacturers' offering of certain devices, specifically unapproved tests, for the diagnosis of disease or other conditions during a declared emergency. This draft guidance encompasses considerations that could be applicable to enforcement policies for all test manufacturers, not only laboratory manufacturers. Submit comments under docket number FDA-2023-D-5365 at www.regulations.gov by July 5, 2024, to ensure the FDA considers comments on this draft guidance before it begins work on the final version of the guidance.

Webinar Details

Registration is not necessary.

Date: June 5, 2024

Time: 1:00 PM - 2:00 PM

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

Use this 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 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)
      • +1 646 828 7666 US (New York)
      • +1 646 964 1167 US (US Spanish Line)
      • +1 415 449 4000 US (US Spanish Line)
      • +1 551 285 1373 US (New Jersey)
      • +1 669 216 1590 US (San Jose)
  • International Caller 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 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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