The U.S. Food and Drug Administration (FDA) has announced a webinar, to provide information on how to comply with establishment registration and device listing requirements for in vitro diagnostic products.

On May 6, 2024, the FDA issued a final rule amending the FDA’s regulations to make explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act) including when the manufacturer of the IVD is a laboratory. Along with that amendment, the FDA outlined a policy to phase out, over the course of four years, its general enforcement discretion approach to laboratory developed tests (LDTs). FDA expects compliance with establishment registration and device listing requirements for most IVDs offered as LDTs by May 6, 2025 (Stage 2 of the phaseout policy).

• Webinar Date: Tuesday, December 3, 2024, from 1:00 PM – 2:00 PM ET
• Location: webcast
• Registration: Not required

View the Webinar Details

If you have questions that you wish to submit for possible discussion during the webinar, please email CDRHWebinars@fda.hhs.gov. All questions must be received by October 31, 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