FDA webinar about final rule regarding laboratory developed tests

May 13, 2024
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 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

Visit the CDC for more information

ID 36875902 © Funniefarm5 | Dreamstime.com
dreamstime_xxl_36875902
ID 336592925 © Yuri Arcurs | Dreamstime.com
dreamstime_xxl_336592925
ID 328976828 © Olga Korshunova | Dreamstime.com
dreamstime_xxl_328976828
ID 170384413 © Transversospinales | Dreamstime.com
dreamstime_xxl_170384413