Webcast | Virtual
Event Title
Webinar - Labeling Requirements for In Vitro Diagnostic Products (IVD), Including LDTs, Under 21 CFR 809.10(b)
September 24, 2024
- Date:
- September 24, 2024
- Time:
- 1:00 p.m. - 2:15 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 labeling requirements for most IVDs offered as LDTs by May 6, 2025 (Stage 2 of the phaseout policy).
On September 24, 2024, the FDA held a webinar to provide information on how to comply with labeling requirements for IVDs, including LDTs. The focus of this webinar was on labeling requirements for test systems, under 21 CFR 809.10(b) and did not cover labeling requirements for other types of IVDs such as collection devices and general purpose reagents.
Webinar Materials
The presentation, printable slides, and transcript are available on 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.