New FDA Webinar on investigational use requirements for LDTs
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 FDA has announced a webinar to provide information on investigational use requirements for IVDs, including LDTs. This webinar will describe the Investigational Device Exemptions (IDE) Regulation (21 CFR Part 812), the regulatory requirements it contains for the study of investigational devices, and FDA’s typical review process for an IDE application. The webinar will be on Tuesday, February 25, 2025 from 2:00 pm to 3:00 pm Eastern Standard Time. No registration is required, but the FDA’s webinar format has limited capacity, and the FDA encourages attendees to join early. In addition, the FDA has stated that it will post a recording and transcript of the webinar.
