Virtual | Virtual
Event Title
Webinar – Registration & Listing Requirements for In Vitro Diagnostic Products (IVDs), Including Laboratory Developed Tests (LDTs)
December 3, 2024
- Date:
- December 3, 2024
- Time:
- 1:00 p.m. - 2:00 p.m. ET
Summary
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). 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).
On December 3, 2024, the U.S. Food and Drug Administration (FDA) held a webinar to provide information on how to comply with registration and listing requirements for IVDs, including LDTs.
Webinar Materials
The presentation, printable slides, and transcript are available on this webpage and at CDRH Learn under "In Vitro Diagnostics."
If you have questions about this webinar, please contact CDRH's Division of Industry and Consumer Education (DICE) at dice@fda.hhs.gov, 1-800-638-2041, or 301-796-7100.