Another Attempt at LDT Oversight, This Time by Statute
Many labs considered the LDT question settled late last year, an understandable reaction but an optimistic one. FDA has been working toward LDT oversight in one form or another for fifteen years, and that persistence shows how important the agency sees the issue. But FDA’s latest attempt to regulate LDTs was another failure; the court vacated FDA’s final rule in March 2025, and the agency rescinded it that September. The status quo was maintained with CMS oversight. FDA kept the authorities it already had, particularly over RUO labeling, but the four-year phase-in that labs had spent two years planning around went away.
On May 19, 2026, Rep. Neal Dunn, R-Florida, who is a physician, introduced HR 8890, the Enhancing Clinical Laboratory Innovation and Access Act of 2026. It is the first legislative attempt at LDT oversight since the court ruling, and it keeps CLIA as the governing framework while adding obligations.
What the bill proposes
The bill would:
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- Confirm that LDTs are professional medical services regulated by CMS under CLIA, effective on enactment;
- Direct CMS to build a public, searchable database of LDTs that includes summaries of performance specifications and validation information;
- Require labs to report test errors that caused serious harm;
- Create an optional route for labs to obtain an affirmation from an approved third party that an LDT is analytically and clinically valid;
- Establish a two-year transition period;
- Allow labs voluntarily keep any clearances or approvals they already hold.
The bill may be amended, but the text shows what a serious proposal for LDT oversight looks like. The major reference laboratories are already engaged because some of the bill’s provisions would change daily practice.
The database provision may spark the most conversation
Right now, a validation file is an internal document made available to surveyors. The surveyor reads it and asks the lab to explain anything that needs explaining. A public database changes that mode completely. Performance specification summaries and validation information would be posted where ordering physicians, health systems, payers, and competing laboratories can all read them, without further discussion or clarification.
A validation file may be technically sound but rely on institutional knowledge, assumptions that aren’t documented, or a reference interval carried forward from a predecessor method. None of that is a problem during an inspection, because you can explain it in person, but a published summary comes with no explanation.
The public database will likely cause labs to spend more time on careful documentation, but this is transparency working as intended.
Serious harm reporting would be new for some labs
IVD manufacturers have reported adverse events for decades, but many CLIA labs have not. A requirement to report test errors that caused serious harm may be unfamiliar work.
The difficult part is not the submission itself. It is everything that comes before it: recognizing that an event might be reportable, documenting the decision when you conclude that it is not, and doing both within a defined timeframe. Most test errors will not meet the serious harm threshold, but the work is in being able to show how that conclusion was reached.
Optional review, and what it offers
The affirmation provision is genuinely voluntary: the bill says a lab may seek one, and separately says the standards cannot require it. The Secretary would approve the third parties, reviews would be limited to 60 days, and FDA is deemed an approved third party automatically, so a lab that wants agency review can request it without the agency taking jurisdiction over the test. Tests approved by the New York State Department of Health, or found reasonable and necessary under MolDX, would be treated as already affirmed.
One consequence is easy to overlook. An affirmation from any approved third party may count as equivalent to FDA clearance or approval for national coverage determinations. That turns a voluntary quality step into an adoption question, the kind decided by payers and hospital committees rather than by the lab.
A manageable action plan
There is no need to act on a bill that hasn’t passed, as many bills never make it into legislation, but two things are worth doing now.
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- Create a single inventory of every LDT the lab runs, its intended use and a note on who established performance for each component, including any RUO material. Most labs already hold this information, but it may not be summarized in one place. This summary will likely be required for the public database provision, but it will be useful to the lab whether the bill passes or not.
- Set up adverse event reporting. Write the SOP, define the reporting trigger, decide who is responsible for the reportability decision, and open the accounts now rather than after an event. Serious harm reporting is the one requirement that has appeared in every version of this discussion, through the draft guidances, the final rule, and now this bill. Whatever else changes, that requirement has not gone away.
The part that does not depend on Congress
The vacatur returned LDT oversight to CMS. It did not settle the validation question, and this bill is evidence that it’s still a priority for regulators.
Whatever happens to HR 8890, the obligation for validation under 42 CFR 493.1253 has not changed. A lab introducing a method that is not cleared or approved must establish performance specifications for it, including accuracy, precision, reportable range, and reference intervals appropriate to the population it serves. That was true before the final rule, during it, and now, but the bill would make that work visible.
A related article appears in the current issue of Medical Laboratory Observer: Build, Buy, or Borrow Risk: Leveraging Regulatory Review as CLIA Modernizes (subscriber access).
CLIA – Clinical Laboratory Improvement Amendments
CMS – Centers for Medical & Medicaid Services
IVD – In vitro Diagnostic
LDT – Laboratory Developed Test
RUO – Research Use Only
SOP – Standard Operating Procedure