05/07/2024: Lab Update: FDA Webinar About Final Rule Regarding Laboratory Developed Tests

CDC's Laboratory Outreach Communication System (LOCS)

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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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)