Federal Judge rules that FDA's attempt to regulate clinical laboratories exceeds its authority

Overview
On March 31, 2025, a federal court vacated the FDA's final rule attempting to regulate laboratory-developed tests (LDTs) as medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA). The ruling is a significant victory for clinical laboratories across the country.

FDA regulates test kits (like home Covid test kits) as "medical devices" and has developed stringent requirements for their manufacture and sale. An LDT is a service, agreed between the patient's medical doctor and the medical doctor in the laboratory, to test the patient's specimen for various "analytes" (antibodies to viruses, hormones, viral particles, etc.). These tests are developed by the laboratory because manufactured kits are not available for the exact test the patient needs. The FDA had asserted a right to regulate LDTs as medical devices.  

The advantage of LDTs is that they can be tailored to fit these needs quickly and for far less cost than asking a kit manufacturer to create a specialized test and obtain FDA approval. LDTs are regulated by the Center For Medicare and Medicaid Services (CMS) and the Clinical Laboratory Improvements Amendments (CLIA) which require the lab to "establish performance characteristics" --prove that the test works as claimed-- and retain the proof for inspection by CMS. 

FDA's decision to regulate LDTs would have resulted in double regulation (CMS and FDA), slowed innovation and cost billions of dollars, which would ultimately be passed on the patient.

The rule would subject about 79,114 existing LDTs and 1,181 labs to FDA premarket reviews, post-market surveillance, and quality system requirements. "FDA acknowledged that the costs of the proposed rule would be significant. Specifically, it estimated that the cost of preparing and submitting [applications] for existing laboratory-developed tests would exceed $35 billion and could reach $113 billion. It also projected that, going forward, annual compliance costs for affected laboratories would range from $4 billion to $14 billion." (From the judgment linked below.)

On March 31, 2025, a federal court vacated the FDA's rule to regulate LDTs as medical devices, marking a significant legal setback for the agency. Judge Sean D. Jordan of the U.S. District Court for the Eastern District of Texas ruled that the FDA lacks statutory authority under the Federal Food, Drug, and Cosmetic Act (FDCA) and CLIA to oversee LDTs, which he characterized as diagnostic services rather than physical medical devices.

The court emphasized that Congress designed CLIA as the primary regulatory framework for clinical laboratories, delegating oversight to CMS rather than the FDA. LDTs were deemed "proprietary methodologies" rather than physical devices, placing them outside the FDA’s jurisdiction.

Of course, FDA may appeal the decision, or Congress may act and change the requirements by law. 

I know laboratories have already spent large amounts attempting to get ready for the May 2025 deadline. (I should have taken up the offer to act as a consultant...too late now.) My advice is to keep doing all the things the FDA has so far required. No harm, and possibly great good, will come from having properly documented complaints procedures and test development and change files beyond the original CLIA requirements. 

The judge's ruling in full.

September 11, 2001

Today’s the anniversary of 9/11. It took place in 2001, long enough ago that students entering the university system this past couple of years were not even born when it took place. It’s starting to fade in living memory and become history, that peculiar domain where historians shuffle facts around until they appear to form a pattern, and then write a book about how that pattern is a thing, a fact in itself, and how this new reified thing was inevitable.

Since the attacks on the World Trade Center – and the other attacks that day – took place in a world with a nascent internet, the process of pattern-making started early. It was one of the first events to be promptly evaluated for slotting into pre-existing patterns, and the conspiracy takes started early. Within minutes, in fact. President Kennedy’s assassination may have spawned more, longer and more elaborate theories but they took a while to grow legs, while 9/11 had its conspiracy theorists firing up the ol’ modems* and spinning their ‘findings’ before the literal dust literally settled.

Photo from Wikimedia Commons (no photographer credit) https://upload.wikimedia.org/wikipedia/commons/4/4e/World-Trade-Center_9-11.jpg

 
I’m not going to rehearse those theories as it’s a futile task. It only adds to the churn. All I’ll say is that within 50 years we’ll get the World Trade Center Deniers who will present plenty of evidence that the WTC buildings never existed and the whole shebang was fabricated to bring the US into open conflicts in the Middle East. Today, thousands of Chat GPT (and similar) queries are generating millions of words of text and hundreds of thousands of pictures, which when put together will cast doubt on anything seen on the internet. There’ll be no such thing as verifiable, original footage.

Maybe that will be the last nail in the coffin of the pattern-matchers – if any and all takes can be fabricated, it will become difficult to wend a path through facts to find any spurious patterns in the data. We’ll just have to see.

On 9/11/2001, as I got ready for work in California, I switched on the TV. I didn’t normally do that, and I have no idea why I did that day. California is three hours ahead of New York. I turned on the cable news to hear a newscaster solemnly intone, “Smoke is rising from the North Tower. The South Tower collapsed minutes ago**.”

I looked at the live picture on the screen and tried to work out what those words could possibly mean. The only two towers I could think of were in the book of the same name by J R R Tolkien. But the picture was not of Middle Earth. It was a city, shrouded in smoke. The announcer talked some more and it eventually penetrated my foggy mind that a World Trade Center building had collapsed – and now another one was on fire. A few minutes later, The North Tower collapsed in a horrific blossom of crushed concrete dust. There was consternation onscreen.

I glanced at the clock. It was 7:30 AM, and I needed to get to work. No one knew what had happened. It’s hard to describe the lack of further information. Today, almost all of us have a high-quality video camera in our pockets. You can’t have a mild row in a suburban street without half-a-dozen bystanders flipping phones out of their pants and recording every detail. Each one can be uploaded to a service and available to watch within minutes. But only 22 years ago, it was a rare occurrence for someone to have both a video camera and the presence of mind to point it at a source of danger rather than leg it out of there as fast as possible. Photos of the planes hitting the towers and the plumes of flame started to come in but still, nothing about it made sense. How could two jets hit two buildings in Manhattan? And something hit the Pentagon building! All aircraft were ordered to land by the FAA!

I’m not sure if I heard about the crash of Flight 93 before I left for work. I know I didn’t see until later the footage of George W Bush reading to a class of schoolkids when an aide whispered something to him and a look I’ve never seen before came over his face. He stayed with the children for a few minutes, apparently not wishing to cause panic, before being hustled to safety.

Once at work you start going about your business, of course. Everyone had a theory, but everyone had work to do. Even so, we would continually drift away from our desks and go to the conference rooms, which had TVs fitted for audio-visual presentations. Our company was (and is) a huge firm performing blood tests on patients all over the US. Vast numbers of vials of blood were shipped around the country from where they were collected to where they could be tested. 

It’s a minor thing among all the horrors that happened on 9/11 (and subsequently) but with all air traffic grounded, we had to find alternate means of getting specimens to the laboratories. Most tests are routine, in the sense that you would be extremely pissed to be told you had to have a second blood draw because your prior specimen didn’t make it to the lab before it denatured, but you wouldn’t suffer a major setback. But other tests are irreplaceable. The “before” samples taken before an operation or cancer treatment saved to be matched with “after” samples. Chemotherapy levels after dosing. Prenatal tests taken from chorionic villi. Drug levels for such things as Gabapentin. Cerebrospinal fluids, bone marrow samples. You don't want either of those done twice.

The logistics departments moved heaven and earth to get everything they could stabilized, if possible, and shifted onto trains and trucks.

One batch of a few hundred specimens could not be recovered and all had to be redrawn. That insulated crate was in the hold of Flight 175 when the plane hit the South Tower. Strange to think that when history is being written and some bright spark has an idea about 9/11, they’ll call for DNA testing of the few preserved pieces of the WTC*** and they might find evidence of a bunch of people who were never in the towers or on the planes, present only as samples in glass vials. 

That could cause a few new conspiracy theories.

 

*All right, it wasn’t that long ago. Many people had cable internet and/or T1 lines, whatever they were.

**That’s from memory, not an exact quote.

*** Most of the rubble was rushed to a landfill, which is more grist for the conspiracy mill. The landfill was called Fresh Kills.

Doctors and nurses to researchers and lab techs

 I'd just like to ignore the massive point of this Rolling Stone article on Republican efforts to deny health care to people it doesn't like, and concentrate on its made-up hierarchy of medical providers, which puts "lab techs" last. 

We Clinical Laboratory Scientists are professionals too. Seventy percent of medical decisions are based on lab results. Without us and our expertise, doctors would be all, "Your pulse is thready and you have lung sounds, rales and rhonchi. You either have a sucking chest wound or a nickel allergy. Take two leeches and call me in the morning, if you're still breathing."