FDA's LDT Rule Is Gone: What Actually Regulates Genetic Tests in 2026
Short answer: In March 2025, a federal court in Texas vacated FDA's 2024 rule asserting device authority over laboratory-developed tests, and FDA did not appeal. As of September 2026, CLIA — administered by CMS, not FDA — remains the primary framework governing LDTs, though a new House bill, H.R. 8890, would make that arrangement permanent by statute.
What actually happened to FDA's LDT rule
On May 6, 2024, FDA published a final rule declaring that laboratory-developed tests are medical devices subject to FDA regulation, with a five-stage phaseout of the agency's decades-old enforcement discretion running through 2028. The rule would have required most LDTs offered by clinical and molecular labs to eventually meet the same premarket review, registration, and adverse-event reporting obligations as commercially distributed in vitro diagnostics.
That rule no longer applies. In Association for Molecular Pathology, et al. v. FDA — consolidated with a challenge brought by the American Clinical Laboratory Association and HealthTrackRX Indiana, Inc. — the U.S. District Court for the Eastern District of Texas vacated the rule nationwide on March 31, 2025. Judge Sean D. Jordan held that FDA lacked statutory authority to regulate LDTs as devices, writing that the text, structure, and history of the Food, Drug, and Cosmetic Act and the Clinical Laboratory Improvement Amendments (CLIA) foreclosed the agency's attempted expansion of jurisdiction: Congress, he wrote, vested authority over laboratory testing regulation in CMS, not FDA. FDA did not appeal the ruling.
Who actually regulates a lab-developed test right now
The vacatur did not create a regulatory vacuum — it returned LDT oversight to the fragmented, multi-agency structure that predated FDA's 2024 rule, and that structure is still in force today. CLIA, administered by CMS, remains the backbone: it governs personnel qualifications, quality control, proficiency testing, and lab certification for essentially every clinical laboratory in the country, regardless of whether it develops its own tests. That is the authority Judge Jordan's ruling said Congress intended all along.
FDA has not left the picture entirely. The agency retains device authority over the tangible components labs buy to build an LDT — commercially distributed reagents, instruments, and analyte-specific reagents — and over software that independently meets the definition of Software as a Medical Device. FDA also continues to enforce Research Use Only and Investigational Use Only labeling restrictions, though legal commentary describes that enforcement as narrowly targeted rather than broad-based. Beyond CMS and FDA, some states run their own parallel review: New York's Clinical Laboratory Evaluation Program has long required separate state approval for LDTs offered to New York residents, independent of whatever FDA does. Voluntary accreditation bodies such as CAP and COLA, and the FTC's authority over deceptive marketing and health claims, round out the rest of the framework labs already comply with.
The bill that would make this permanent: H.R. 8890
The first serious congressional response to the vacatur arrived over a year after the ruling. On May 19, 2026, Rep. Neal Dunn, M.D. (R-FL-2) introduced H.R. 8890, the Enhancing Clinical Laboratory Innovation and Access Act of 2026 — referred to in industry commentary as the Enhancing CLIA Act. Rather than reviving FDA device authority, as the long-stalled VALID Act would have done in earlier Congresses, the bill codifies CMS and CLIA as the statutory home for LDT oversight.
As written, the bill would require labs to demonstrate "reasonable assurance of analytical and clinical validity" for LDTs, including tests that analyze patient-specific digital laboratory data. It stops short of mandatory premarket review: labs could instead seek a voluntary "supplemental affirmation" of a test from an approved third party, which could include FDA itself. The bill also directs CMS to build a centralized database of LDT information and would require labs to report errors when an inaccurate result causes serious patient harm. It updates CLIA's specialty categories to reflect molecular diagnostics, digital pathology, and next-generation sequencing — categories the 1992 CLIA regulations were never written to anticipate.
What this means for labs, medical directors, and RCM teams right now
For a molecular or genetic testing lab operating today, the practical baseline has not changed since the vacatur: LDTs you validate and run in-house are governed by your CLIA certificate, your CAP or COLA accreditation, and any state-specific rules (New York above all), not by FDA premarket review. That means the compliance obligations that determine whether you can bill a test at all — CLIA personnel and quality requirements, and separately, payer coverage and prior-authorization rules like MolDX registration — are the ones to keep current, since those, unlike FDA device status, were never in question. Our coverage of CMS's own CLIA modernization RFI tracks the parallel, agency-side effort to update those 1992 regulations, separate from H.R. 8890.
That said, treating the current arrangement as permanent would be a mistake. Legal commentary following the one-year mark of the vacatur is explicit that companies should "assess their LDT portfolios, identify higher-risk tests, and build regulatory strategies that can adapt to future federal action" rather than wait for legislative certainty. H.R. 8890 is a single bill from one member of a divided Congress, introduced with the legislative calendar narrowing ahead of the November 2026 elections; it has not been enacted, and nothing requires that its specific validity and reporting standards survive committee unchanged, if the bill moves at all. Labs with strong analytical and clinical validation files today are positioned to meet whatever documentation standard eventually gets written into law, whether that is H.R. 8890's "reasonable assurance" language, a future FDA-authority bill, or simply continued CLIA-only oversight. None of this changes how a test gets paid for once it is run: that question sits with CMS coverage policy and commercial payers, covered in our Medicare coverage overview for genetic testing.
FAQ
Is FDA's 2024 LDT rule still in effect?
No. The U.S. District Court for the Eastern District of Texas vacated the rule nationwide on March 31, 2025, in Association for Molecular Pathology v. FDA, and FDA did not appeal. The rule imposes no obligations on labs today.
If FDA doesn't regulate LDTs, who does?
CMS, through CLIA, remains the primary framework governing clinical laboratories and the LDTs they run. FDA retains authority only over the device components labs purchase (reagents, instruments) and over qualifying software; some states, notably New York, add their own separate LDT review.
What would H.R. 8890 change?
It would write CMS/CLIA's current role into statute, require labs to show "reasonable assurance" of analytical and clinical validity, create a voluntary third-party affirmation option, build a centralized CMS test database, and require reporting of errors that cause serious patient harm. It was introduced May 19, 2026, and has not been enacted.
Does the vacatur mean LDTs are unregulated?
No. It means LDTs are regulated the way they were before May 2024: through CLIA certification, state programs where applicable, and voluntary accreditation, rather than through FDA device review, registration, and premarket submission requirements.
Should labs stop investing in test validation documentation?
No. Legal advisories following the one-year anniversary of the vacatur recommend labs keep building robust analytical and clinical validity files precisely because the regulatory landscape (CLIA modernization, H.R. 8890, or a future FDA effort) remains unsettled and could require that documentation later.
This article is provided for general educational and business-decision-support purposes for laboratory, medical-director, genetic-counseling, and revenue-cycle professionals. It is not legal or regulatory advice for any specific test, product, or organization, and the legislative and regulatory landscape described here is subject to change. Consult qualified regulatory or legal counsel before making compliance decisions based on the status of any bill or rule. Learn more about how ScreenMyGene supports compliant genetic testing workflows at screenmygene.com.
Sources: The FDA Law Blog, "Federal District Court Vacates FDA's Laboratory Developed Tests Final Rule" (Apr. 2025); Sidley Austin, "FDA's Laboratory-Developed Test Rule Struck Down in Major Test of Loper Bright" (Apr. 2025); Arnold & Porter, "Oversight of Laboratory Developed Tests One Year After ACLA v. FDA: Assessing Legislative Proposals in Context" (Jul. 2026); Covington & Burling, "Enhancing Clinical Laboratory Innovation and Access Act (Enhancing CLIA Act) of 2026" (Jun. 2026); Haynes Boone, "FDA Reverses Final Rule Regulating Laboratory Developed Tests"; MedTech Dive, "FDA rescinds LDT final rule."