> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Final Rule on Lab-Developed Tests
- URL: https://www.fdaweb.com/final-rule-on-lab-developed-tests/
- Published: 2024-05-01T12:00:00.000Z
- Updated: 2026-09-14T14:29:42.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5156894

*Federal Register* notice: FDA is issuing a final rule to amend its 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. Additionally, the agency is phasing out its general enforcement discretion approach for laboratory-developed tests (LDTs) so that IVDs manufactured by a laboratory will generally fall under the same enforcement approach as other IVDs. This phaseout policy includes enforcement discretion policies for specific categories of IVDs manufactured by a laboratory, including currently marketed IVDs offered as LDTs and LDTs for unmet needs. To view the notice, click [here](https://public-inspection.federalregister.gov/2024-08935.pdf?ref=fdaweb.com).