Data / Federal rules / 2024-08935
Medical Devices; Laboratory Developed Tests
The Food and Drug Administration published this final rule in the Federal Register on May 6, 2024. It took effect on July 5, 2024.
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What the agency says
The Food and Drug Administration 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 (FD&C Act) including when the manufacturer of the IVD is a laboratory. In conjunction with this amendment, the Food and Drug Administration 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. This phaseout policy is intended to better protect the public health by helping to assure the safety and effectiveness of IVDs offered as LDTs, while also accounting for other important public health considerations such as patient access and reliance.
Key facts
- Document number
- 2024-08935
- Type
- Final rule
- Action
- Final rule
- Agency
- Health and Human Services Department; Food and Drug Administration
- Published
- May 6, 2024
- Takes effect
- July 5, 2024
- Dates
- This rule is effective July 5, 2024.
- Docket
- Docket No. FDA-2023-N-2177
- Regulation ID (RIN)
- 0910-AI85
- Code of Federal Regulations
- 21 CFR 809
- Topics
- Labeling; Medical devices
- Pages
- 160
Other documents from the Food and Drug Administration
Everything from the Food and Drug Administration · Rules on labeling · Rules on medical devices · Published in May 2024
Read from the Federal Register API, last updated 2026-10-23. The document on federalregister.gov is the official record; dates and dockets can change through later corrections. Free to reuse with credit to SpecStream under CC BY 4.0.