The Enhancing CLIA Act of 2026: What H.R. 8890 means for laboratory developed tests

For two years, the rules governing laboratory developed tests have been unsettled. A federal rule tried to bring them under FDA device regulation, a court struck that rule down, and now a new bill in Congress wants to write the resulting arrangement permanently into law—while adding oversight the old rules never had.

Here's what's actually in the bill, where it stands, and what it would mean for reference labs and larger physician-owned labs running their own assays.

A laboratory developed test, or LDT, is a diagnostic test designed, validated, and performed entirely within a single laboratory, rather than a commercial kit manufactured and sold to other labs. The same lab that builds the test is the one running it on patient samples.

LDTs have historically been regulated as professional lab services under the Clinical Laboratory Improvement Amendments (CLIA), rather than as manufactured products under FDA's device rules. They're especially common in genomic and genetic testing, rare-disease diagnostics, and precision oncology—areas where commercial test kits often don't exist or can't keep pace with the science.

The current fight over LDT oversight traces back to a 2024 FDA rule. In May of that year, FDA finalized a rule declaring LDTs to be medical devices under the Food, Drug, and Cosmetic Act, with plans to phase in device-level requirements over roughly four years.

The American Clinical Laboratory Association (ACLA), along with member lab HealthTrackRx, sued to block the rule.

A related suit from the Association for Molecular Pathology was consolidated with ACLA's case in the U.S. District Court for the Eastern District of Texas.

On March 31, 2025, the court vacated FDA's rule in its entirety, ruling that FDA's attempt to regulate lab testing services as medical devices exceeded the agency's statutory authority. The court decided that "devices" under federal law are commercial articles, not the professional services labs and physicians perform, and Congress had already built a separate framework, CLIA, specifically to govern laboratory services. The Department of Health and Human Services chose not to appeal, so the ruling stands.

That ruling settled the jurisdictional question in court, but a court decision isn't a statute. It can be tested again in future litigation, or reinterpreted by a future FDA under different legal theories. That's the gap H.R. 8890 is designed to close.

Representative Neal Dunn (R-FL), a physician, introduced the Enhancing Clinical Laboratory Innovation and Access Act of 2026, known as the Enhancing CLIA Act, on May 19, 2026.

The bill takes what the court decided and writes it directly into the text of CLIA and the FDCA, while adding five things CLIA has never had before:

• A public database of LDT performance and validation data
• A verification step when the performing lab isn't the developing lab
• An optional third-party or FDA "supplemental affirmation" pathway
• Centralized reporting for test errors that cause serious harm
• Modernized CLIA specialty categories for molecular diagnostics, digital pathology, and next-generation sequencing

A new, public LDT database

For tests already in clinical use, labs would have a defined window after enactment to submit their performance-specification and validation data—the actual mechanics behind the CMS LDT database requirement. Tests launched after that transition point would follow the same disclosure standard going forward, tying database entry to the point a test first goes into clinical use instead of a one-time compliance deadline.

Verification between developing and performing labs

This verification workflow would only kick in when two different labs are involved. A lab that both develops and runs its own test wouldn't trigger it.

When the performing lab is required to verify the developing lab's performance specs before clinical use, that verification becomes a documented, auditable step, not just an internal courtesy check.

Voluntary third-party or FDA "Supplemental Affirmation"

Seeking affirmation doesn't replace the underlying validity standard every LDT must meet. It's an additional, optional layer on top of it.

A lab that skips this pathway would still have to meet the bill's baseline analytical and clinical validity requirements. A lab that pursues it would pay a fee comparable to an FDA premarket notification fee in exchange for outside confirmation it's met that bar.

Test error reporting

The reporting trigger proposed in H.R. 8890 would be tied to specific legal definitions, not general quality complaints.

Per the bill text, "serious harm" means a misdiagnosis or failure to diagnose that causes the absence, delay, or discontinuation of critical treatment (or the administration of unnecessary treatment) resulting in death or serious injury to the patient. This is a defined threshold, not a catch-all for any test discrepancy.

Modernizing CLIA specialties

This provision runs on a fixed clock: CMS would have 180 days after enactment to propose new specialty categories, separate from anything tied to LDT oversight specifically. It's the one part of the bill aimed at CLIA's structure broadly instead of at test validity or reporting.

As of this writing, H.R. 8890 faces a fairly typical set of early-stage headwinds:

• No cosponsors
• No companion bill in the Senate
• Rep. Dunn is not seeking re-election at the end of this term

H.R. 8890 is currently parked with the House Energy and Commerce and Ways and Means Committees, per GovTrack's bill tracker, which puts its odds at a 6% chance of clearing committee and just a 2% chance of being enacted. Most introduced bills never reach a floor vote at all.

It isn't without support, though. In an official statement, the ACLA said it appreciates Rep. Dunn's approach to updating CLIA and welcomed the bill's reaffirmation that CMS, not FDA, regulates clinical laboratories.

ARUP Laboratories—a nonprofit reference laboratory affiliated with the University of Utah's Department of Pathology—has also weighed in directly: its chief medical officer called the bill "an important proposal" that will hopefully spark crucial conversations across the clinical laboratory community. ARUP separately said the bill has the potential to strengthen innovation and transparency in laboratory medicine.

There's also a parallel track to watch.

CMS itself has a Request for Information on its CLIA regulations that cleared OMB review in early July 2026, according to a client advisory from the law firm Arnold & Porter, though it had not yet formally published in the Federal Register as of this writing.

That kind of regulatory process can move independently of whether Congress acts on H.R. 8890, and it may reach some of the same outcomes faster than the bill would.

Once that notice does publish, it's the direct, non-partisan channel for labs to weigh in on CLIA's future—separate from anything tied to this specific bill's fate. Notably, H.R. 8890 would also create its own standing version of this mechanism: a requirement that CMS review CLIA regulations at least once every five years, issuing a fresh Request for Information and public comment docket each time.

One health policy analyst has speculated further on the bill's purpose: given the sponsor's retirement and the bill's detailed, fully worked-out language, it may function as a marker—a fully drafted proposal ready to be picked up later, rather than a bill built for immediate passage.

The core disagreement in the industry is about what kind of oversight fits an LDT. Under CLIA, the government certifies the laboratory itself—its personnel, quality control, and proficiency testing—and CMS allows labs to update and revalidate their own tests as science evolves. Under FDA's device framework, any modification to a test would instead require new FDA filings and authorization, similar to how a physical medical device is regulated.

The industry argument for keeping LDT oversight in CLIA is speed and fit: because LDTs don't go through FDA's premarket approval process, labs can adapt tests quickly as science advances, and can build tests for rare diseases or unusual biomarkers where a commercial kit would never be economically viable.

FDA's original rationale for wanting oversight was different: the agency argued CLIA doesn't require labs to establish clinical validity, only analytical validity, and that some modern LDTs, especially algorithm-driven tests, behave more like commercial devices than traditional lab assays.

In practice, the gap is narrower than it sounds: more than 8,000 laboratories are accredited by the College of American Pathologists or the Joint Commission, and both accrediting bodies require documented clinical validation for any LDT used in patient care. For a large share of the industry, clinical validity documentation isn't a hypothetical FDA-only requirement. It's a longstanding condition of accreditation.

Before any lab directors start to worry, remember that this bill has not passed, and even if it does, most provisions wouldn't take effect until two years after enactment. With that in mind, the bill does preview a set of LDT compliance requirements that would touch four areas of a lab's operations:

• Database readiness: Labs would eventually need a way to compile and submit performance-specification and validation data for their LDTs to CMS's new database
• Verification records between labs: When a performing lab isn't the developing lab, documentation proving the performance specifications were verified before clinical use would become a requirement, not just a best practice
• Sign-off and audit trail: Whether or not a lab pursues supplemental affirmation, having a clean, exportable record of who validated a test and when would matter more under this framework
• Error tracking against a defined standard: Because the bill's error-reporting requirement is tied to specific legal definitions of harm and injury, labs would benefit from error-tracking systems that can map cleanly to those categories

None of this adds up to premarket approval, though. The bill doesn't ask CMS to pre-approve each test before it's used. The model is closer to labs attesting to meeting the standard and disclosing their data publicly, with CMS able to step in "for cause" if there's credible evidence a test isn't valid—not a premarket review queue.

How much this changes for a given lab depends on where that lab is starting from. For CAP- or Joint Commission–accredited labs already documenting clinical validity, the heavier lift isn't proving validity for the first time, it's centralizing and exporting proof into a new, publicly disclosed format. For labs operating closer to CLIA's baseline requirements today, the compliance gap to close would be larger.

To be direct about it: this is still hypothetical. The bill hasn't passed, and CMS hasn't defined the actual data format or fields the eventual LDT database would require. Anyone claiming full readiness for a regulatory framework that doesn't exist yet would be getting ahead of the facts.

Even so, CompuGroup Medical's existing lab infrastructure lines up well with the direction of this bill.

CGM LABSIGN is built for sign-off and compliance recordkeeping, which is exactly the kind of verification and audit trail the bill's documentation requirements point toward. In addition, HL7-based exports are already the standard mechanism for moving data out of our lab systems, including CGM LABDAQ and CGM SCHUYLAB.

The honest gap is that nobody yet knows the specific schema—the exact data fields and format—CMS would require for a public LDT database, because that database doesn't exist. Some field-level mapping or data reformatting would likely be needed once specifications are defined, but based on the export capability in place today, that adaptation looks more like configuration than a rebuild.