A Texas court vacated the FDA's lab developed tests rule on March 31, 2025, and the agency removed its text that September. Here is the timeline, what CLIA still covers, and what I could not confirm.
The FDA’s lab developed tests rule is no longer in force. A federal court in Texas vacated it on March 31, 2025, and the agency formally removed the rule’s language from its regulations on September 19, 2025. The FDA’s own lab developed tests page, last updated in September 2025, shows no newer action. Labs that build their own diagnostic tests are back to the oversight they had before May 2024.
This post covers US federal law. It separates what I could confirm from primary sources from what I could not, because the question has an open end: whether the FDA or Congress will try again.
Where things stand, in one table
| Date | What happened | Source type |
|---|---|---|
| May 6, 2024 | FDA publishes a final rule (89 FR 37286) amending 21 CFR 809.3 so in vitro diagnostic products are devices “including when the manufacturer of these products is a laboratory.” Effective July 5, 2024. | Federal Register |
| March 31, 2025 | In American Clinical Laboratory Association v. FDA, No. 4:24-CV-479-SDJ, the US District Court for the Eastern District of Texas vacates the rule and remands it to HHS. | Federal Register, FDA page |
| September 19, 2025 | FDA publishes a rule (90 FR 45134) deleting the added words from 21 CFR 809.3(a), restoring the earlier text. Effective on publication. | Federal Register |
| Through October 10, 2026 | FDA’s LDT page lists no further action. | FDA page, read on this date |
What a lab developed test is, and why anyone cared
A laboratory developed test, or LDT, is a diagnostic test designed, made and used within a single laboratory, rather than a kit sold to many labs. Think of a genetic panel a hospital lab builds to look for cancer-linked variants, or a specialty assay for a rare condition. For decades the FDA had the legal authority to treat these as medical devices but, by long practice, generally chose not to enforce its premarket and other device requirements against them.
The 2024 rule tried to end that practice. FDA’s reasoning, as the Federal Register text lays it out, was that the device definition in the Federal Food, Drug, and Cosmetic Act does not depend on who makes a product, and that the old justification for discretion no longer fit. LDTs were once described as small-volume, local and simple. FDA said they are now used more widely, rely on complex instrumentation and software, often run in high volume, and inform serious clinical decisions. It also cited worries about misdiagnosis, cybersecurity and inconsistent validation.
The phase-in that never took hold
The rule did not apply everything at once. It laid out a five-stage schedule counted from the May 2024 publication date, so the stages below are approximate calendar points.
- About May 2025: medical device reporting, correction and removal reporting, and complaint files.
- About May 2026: registration and listing, labeling, and investigational use requirements.
- About May 2027: quality system requirements other than complaint files.
- About November 2027: premarket review for high-risk tests.
- About May 2028: premarket review for moderate- and low-risk tests that need it.
The rule also listed categories where FDA generally would not enforce certain requirements, including so-called 1976-type LDTs, certain HLA tests for transplantation, forensic tests, tests from Veterans Health Administration and Department of Defense labs, tests approved by New York State’s clinical laboratory evaluation program for premarket review, unmet-need tests inside integrated health systems, and tests already on the market and not significantly modified. With the vacatur, none of this schedule applies. The FDA’s 2025 rule notes the phaseout policy is no longer in effect.
How the fight got here
FDA’s proposal, published October 3, 2023 (88 FR 68006), drew 6,707 comments on Regulations.gov before the December 4, 2023 deadline, according to the Federal Register page. The history it recites runs back further. The 1976 Medical Device Amendments created the modern device system, and FDA mostly did not apply it to LDTs, which were then small-volume local tests. In 1997 it restricted analyte specific reagents, the main ingredients of most LDTs. It floated draft guidance in 2006 and 2014, and in 2017 chose not to finalize the 2014 drafts. In August 2020 an HHS statement said FDA would not require premarket review of LDTs without notice-and-comment rulemaking, and HHS withdrew that statement in November 2021 after new legal advice.
To justify acting, FDA pointed to examples of test problems. Among them, it cited a 2016 false positive from a long QT genetic test that led to an unnecessary defibrillator implant, a 2015 FDA report of 20 case studies of LDTs that caused or may have caused harm, and a ProPublica report that a university-contracted COVID-19 test missed 96% of positive cases. These are FDA’s selections, offered in support of its rule. A laboratory trade group, the American Clinical Laboratory Association, sued over the rule, and I did not read its filings, so treat the examples as the agency’s argument rather than settled findings.
FDA also estimated annualized benefits of $31.41 billion over 20 years against annualized costs to laboratories of $5.87 billion, at a 7% discount rate. Those are the agency’s projections for a rule that never took full effect.
How the court got there
The FDA’s September 2025 document says the agency was acting to reflect the Texas court’s order. It called the change ministerial, which is why it skipped notice and comment and took effect the day it was published, finding good cause to skip the usual 30-day waiting period. The document does not discuss the court’s reasoning in detail, and it does not say whether the FDA appealed. I could not confirm an appeal either way, so I do not state one. Anyone relying on this point should check the case docket.
What the record does show is the narrowness of the September 2025 move. FDA did not announce a new LDT policy. It removed one phrase from one definition and returned the text to its prior form. Why it matters is simple: a vacated rule carries no compliance dates, so the calendar FDA published in 2024 stopped meaning anything for laboratories. Whether the agency, the Department of Health and Human Services or Congress takes another route is not something the sources I read answer.
Who regulates these tests now
Laboratories still operate under the Clinical Laboratory Improvement Amendments, known as CLIA, which the Centers for Medicare & Medicaid Services administers. CMS describes the program as regulating laboratory testing performed on humans in the United States for health assessment or the diagnosis, prevention or treatment of disease, with requirements that scale with test complexity and about 320,000 laboratory entities covered. The program’s stated aim is accurate, reliable and timely results.
New York is a separate layer: the 2024 rule itself referred to the New York State clinical laboratory evaluation program as a route for premarket review of some LDTs. Other state requirements vary and I have not surveyed them.
The difference between the two federal systems is the sticking point in the dispute. FDA’s premarket review looks at the test as a product. CLIA concentrates on the laboratory. FDA’s 2024 explanation cited inconsistent validation as a reason to want more product-level oversight, while the CMS page I read does not discuss clinical validity at all.
What this means in practice
For patients
A test ordered from a hospital or reference lab is generally not an FDA-cleared product if the lab developed it. That was true before 2024 and is true now. If a result will drive a major decision, it is reasonable to ask the ordering clinician how the test was validated and whether a confirmatory method exists.
For laboratories
The compliance dates that would have arrived in 2025 and 2026 are void, so registration and device reporting for LDTs are not required under the vacated rule. Labs should still follow CLIA and any state requirements, and watch for new FDA or congressional action.
For test developers
Kits and instruments sold to multiple labs remain regulated as devices in the ordinary way. The vacated rule concerned labs that manufacture tests for their own use.
Related questions
Is the LDT rule canceled or just paused?
It was vacated, meaning set aside, by a federal court, and FDA then removed its text from the regulations. That is more than a pause. A future rule would have to be written and issued anew.
Does the FDA still have authority over lab developed tests?
The court’s order concerned the 2024 rule. I did not read the opinion itself, so I cannot say how broadly it treated FDA’s underlying authority. Check the opinion before drawing conclusions beyond what the agency’s documents say.
What could change this?
Possible routes include a new FDA rulemaking, legislation or an appellate ruling. I found no confirmation of any of them. This is general information, not legal advice.
Sources
- U.S. Food and Drug Administration, Laboratory Developed Tests
- Federal Register, Medical Devices; Laboratory Developed Tests; Implementation of Vacatur (Sept. 19, 2025)
- Federal Register, Medical Devices; Laboratory Developed Tests proposed rule (Oct. 3, 2023)
- Federal Register, Medical Devices; Laboratory Developed Tests final rule (May 6, 2024)
- Centers for Medicare & Medicaid Services, Clinical Laboratory Improvement Amendments
