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- FDA to Host Oct. 31 Webinar on Laboratory-Developed Tests Proposed Rule
On Tuesday, October 31 the US Food and Drug Administration (FDA) will host a webinar to provide information on the proposed rule regarding laboratory-developed tests (LDTs). Registration is not necessary. The presentation, printable slides, and transcript from the webinar will be available at CDRH Learn under “In Vitro Diagnostics.”
Separately, due to the complexity of the rule and implications for laboratory testing, the CAP is calling on the FDA to extend the comment period to at least 120-days to give stakeholders more time to review the proposal and respond. The proposed rule calls for public comment and recommendations for alternative enforcement approaches.
During the webinar, the FDA will:
- Provide an overview of the rulemaking proposal to amend the FDA’s regulations to make explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act including when the manufacturer of the IVD is a laboratory.
- Describe the proposed phaseout of FDA’s general enforcement discretion approach to LDTs.
- Host a Q&A session based on questions submitted by Monday, Oct. 23 at CDRHWebinars@fda.hhs.gov. Questions will not be taken during the live webinar.
Date: October 31, 2023
Time: 1:00 PM - 2:00 PM ET
Click this link to join the webinar: https://fda.zoomgov.com/j/1601249212?pwd=UnlIbThyOXN2R3gvTGJveERxRXpUdz09External
Passcode: k+S8kN
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
- +1 669 216 1590 US (San Jose)
- International Caller Dial: Please check the international numbers available
- Webinar ID: 160 124 9212
- Passcode: 298020
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.