- October 31, 2023
- 1:00 PM - 2:00 PM ET
On October 31, 2023, the U.S. Food and Drug Administration (FDA) held a webinar to provide information on the proposed rule regarding Laboratory Developed Tests or LDTs.
During the webinar, the FDA:
- Provided an overview of the rulemaking proposal to amend the FDA’s regulations to make 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
- Described the proposed phaseout of FDA’s general enforcement discretion approach to LDTs.
The FDA has generally considered laboratory developed tests, or LDTs, to be in vitro diagnostic products (IVDs) that are intended for clinical use and are designed, manufactured, and used within a single clinical laboratory that meets certain laboratory requirements as described in the rulemaking proposal.
On September 29, 2023, the FDA announced this proposed rule: Medical Devices; Laboratory Developed Tests. The proposed rule seeks to amend the FDA’s regulations to make explicit that IVDs are devices under the Federal Food, Drug, and Cosmetic Act, including when the manufacturer of the IVD is a laboratory. Along with this amendment, the FDA is proposing a policy under which the FDA intends to provide greater oversight of LDTs, through a phaseout of its general enforcement discretion approach to LDTs.
The FDA believes this proposal would also advance responsible innovation by both laboratory and non-laboratory IVD manufacturers alike by better assuring the safety and effectiveness of IVDs offered as LDTs and removing a disincentive for non-laboratory manufacturers to develop novel tests.
The presentation, printable slides, and transcript are available 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 email@example.com, 1-800-638-2041, or 301-796-7100.