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05/07/2024: Lab Update: FDA Webinar About Final Rule Regarding Laboratory Developed Tests
Audience: Clinical Laboratories
Level: Laboratory Update
On May 14, 2024, the U.S. Food and Drug Administration (FDA) is hosting a webinar to discuss the final rule “Medical Devices; Laboratory Developed Tests” (LDTs). FDA will provide an overview of the final rule amending the FDA’s regulations to make it 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; and describe the phaseout of the FDA’s general enforcement discretion approach to LDTs.
If you have questions about this final rule that you wish to submit for possible discussion during the webinar, please email CDRHWebinars@fda.hhs.gov. All questions must be received by May 7, 2024, to be considered for the discussion. Questions will not be taken during the live webinar.
If you have questions about this webinar, contact the Division of Industry and Consumer Education.
- Webinar Date: Tuesday, May 14, 2024, from 1:00 PM – 2:00 PM ET
- Location: Webcast
- Registration: Not required
More information and links to the webinar can be found here.
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Online Resources
- Final Rule: Medical Devices; Laboratory Developed Tests | FDA Webinar
- Webinar Outlook Calendar invite
Questions?
- If you are a clinical or public health laboratory professional, contact LOCS.
- For media inquiries, contact the CDC Newsroom.
- For all other questions, contact CDC-INFO.
Thank you,
The Laboratory Outreach Communication System
Laboratory Outreach Communication System (LOCS) | Division of Laboratory Systems (DLS)
Center for Laboratory Systems and Response (CLSR)
Centers for Disease Control and Prevention (CDC)