 
On May 6, 2024, the U.S. Food and Drug Administration (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). The FDA expects compliance with investigational use requirements for most IVDs offered as LDTs by May 6, 2026.
The U.S. Food and Drug Administration (FDA) is announcing a webinar to provide information on investigational use requirements for in vitro diagnostic products (IVDs), including laboratory developed tests (LDTs). This webinar will describe the Investigational Device Exemptions (IDE) Regulation (21 CFR Part 812) and the regulatory requirements it contains for the study of investigational devices, and FDA’s typical review process for an IDE application.
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Webinar Date: Tuesday, February 25, 2025, 2:00 PM – 3:00 PM ET
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Location: Webcast
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Registration Deadline: Not required
We anticipate high attendance for this webinar and there is limited capacity. We encourage you to join early. However, due to the limited capacity we intend to post a recording and transcript as soon as possible following the webinar.
Questions?
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 January 24, 2025, to be considered for the discussion. Questions will be not be taken during the live webinar.
If you have questions about this webinar contact the Division of Industry and Consumer Education.
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