Webcast
Event Title
Webinar - Proposed Rule: Medical Devices; Laboratory Developed Tests
October 31, 2023
- Date:
- October 31, 2023
- Time:
- 1:00 PM - 2:00 PM ET
Summary
On October 31, 2023, the U.S. Food and Drug Administration (FDA) will host a webinar to provide information on the proposed rule regarding Laboratory Developed Tests or LDTs.
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 that have been submitted prior to the webinar at CDRHWebinars@fda.hhs.gov. Questions will not be taken during the live webinar. All questions are due by October 23, 2023, to be considered for the discussion.
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Background
The FDA has generally considered laboratory developed tests, or LDTs, to be in vitro diagnostic products (IVDs) that are intended for clinical use and are designed, manufactured, and used within a single clinical laboratory that meets certain laboratory requirements as described in the rulemaking proposal.
On September 29, 2023, the FDA announced this proposed rule: Medical Devices; Laboratory Developed Tests. The proposed rule seeks to amend the FDA’s regulations to make explicit that IVDs are devices under the Federal Food, Drug, and Cosmetic Act, including when the manufacturer of the IVD is a laboratory. Along with this amendment, the FDA is proposing a policy under which the FDA intends to provide greater oversight of LDTs, through a phaseout of its general enforcement discretion approach to LDTs.
The FDA believes this proposal would also advance responsible innovation by both laboratory and non-laboratory IVD manufacturers alike by better assuring the safety and effectiveness of IVDs offered as LDTs and removing a disincentive for non-laboratory manufacturers to develop novel tests.
Webinar Details
Registration is not necessary.
Date: October 31, 2023
Time: 1:00 PM - 2:00 PM ET
Please dial in 15 minutes before the start of the call to allow time to connect.
Please click the link below to join the webinar:
https://fda.zoomgov.com/j/1601249212?pwd=UnlIbThyOXN2R3gvTGJveERxRXpUdz09
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)
- For higher quality, dial a number based on your current location:
- International Caller Dial: Please check the international numbers available
- Webinar ID: 160 124 9212
- Passcode: 298020
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.