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Lexi Sharkov05/22/245 min read

What does the FDA’s latest ruling on Laboratory Developed Tests mean for Quality teams?

On April 29, 2024, the FDA announced a final rule clarifying that Laboratory Developed Tests (LDTs) are officially categorized as medical devices and are subject to their same oversight. This ruling is significant for laboratories and will have a noticeable impact on the Quality teams that keep them compliant. Keep reading to learn what the ruling entails, what it means for labs that produce LDTs, and how Quality teams can prepare for the changes in regulation. 

But before we jump in, here’s a refresher on some important terms: 

  • In Vitro Diagnostic Products (IVDs): In vitro diagnostic products are used to collect, prepare, and examine blood, saliva, tissue, and other samples taken from the body.

  • IVD Classification: The FDA divides IVDs into three classes based on the level of control necessary to assure the safety and effectiveness of the device and their potential risk to the patient. Class I contains devices with the lowest risk (think bandages or handheld surgical instruments), Class II contains those with moderate risk (think pregnancy tests or blood pressure cuffs), and Class III includes those with the greatest risk (think HIV test or cancer diagnostics).

  • Laboratory Developed Tests (LDTs): Laboratory developed tests are IVDs that are made and used within a single laboratory. These tests are often used to detect certain diseases or conditions, as well as determine a person’s risk for developing various diseases, such as cancer. 
  • CLIA: CLIA is the Clinical Laboratory Improvement Amendments of 1988 which historically set the regulatory standards for LDTs. 

The FDA’s latest ruling on LDTs summarized 

To date, CLIA has managed the oversight and regulation of LDTs, with the FDA taking an “enforcement discretion” approach. However, as LDTs become more widespread and integral in medical decisions (think prenatal screening, COVID-19 testing, or cancer diagnostics), the potential for patient harm due to faulty testing increases. And when patient health is on the line, the FDA takes notice.

This ruling signifies the FDA taking a more active approach in enforcement and ramping up its oversight of LDTs. That means stricter quality system requirements, reporting, labeling regulations, pre-market approvals, and more, similar to those faced by medical devices.    

The LDT ruling timeline

Thankfully, laboratories will have time to adjust to the new regulations and put new quality processes in place. The FDA is utilizing a five-stage phaseout policy over the course of four years which will require LDTs to meet specific regulations during each stage. The stages are:  

  • Stage 1 - May 6, 2025: The FDA will expect LDT compliance with:  
    • Medical device reporting (MDR) requirements  
    • Correction and removal reporting requirements
    • Quality system requirements specific to complaint files 
  • Stage 2 - May 6, 2026: LDTs must comply with requirements not covered during other stages of the phaseout policy, including:
    • Registration and listing requirements
    • Labeling requirements (test labels, reagents, packaging, etc.)  
    • Investigational use requirements 
  • Stage 3 - May 6, 2027: LDTs are expected to comply with quality system requirements including: 
    • Design controls
    • Purchasing controls
    • Acceptance activities
    • CAPA
    • Records requirements.
  • Stage 4 - November 6, 2027: High-risk IVDs offered as LDTs must comply with premarket review regulations. If a premarket submission is received by this date, the FDA will exercise enforcement discretion during the review process. 
  • Stage 5 - May 6, 2028: Moderate- and low-risk IVDs offered as LDTs must comply with premarket review regulations. If a premarket submission is received by this date, the FDA will exercise enforcement discretion during the review process. 

What the LDT ruling means for labs and their Quality teams

The FDA’s position on LDT regulation enforcement is easy to understand. They see a gap in patient safety and are taking action. However, it’s important to recognize the push and pull between increased oversight and barriers that slow the delivery of cutting-edge science to patients.

Small, innovative startups that may have had very little interaction with the FDA are now about to venture into a new frontier – complete with some hefty overhead.

While CLIA maintained standards for training, safety, validations, etc., inspectors typically evaluated laboratories creating LDTs from an operational standpoint (i.e. Are you running a safe and organized lab? Do you have the necessary personnel in place? Are you reporting the way you’re supposed to do?) With the latest change, labs will need to overhaul their quality management systems (QMS). Because LDTs are now subject to medical device oversight, labs must submit design specifications and extensive validation to the FDA before offering tests to patients. These organizations should also expect a back and forth after submission. It won’t be uncommon (especially as teams get used to the new requirements) for the FDA to require revalidation, adjustments to studies, and more. From document control and training, to CAPAs and client complaints, laboratories will have to suddenly manage, track, and report on a lot.  

Another hurdle? Labs will now find themselves in a queue as the FDA takes submissions from all labs running LDTs. The FDA is planning to accommodate the submissions that will result from this new ruling, but there are likely to be some unexpected delays during the review process.

Not only does this mean longer time frames to bring tests to market, it means laboratories will need to up their investment in both Quality teams and tools if they want to continue bringing innovation and value to patient populations. 

What Quality teams can do to prepare for LDT ruling enforcement

Laboratories and their Quality teams have exactly one year to prep for the rollout of the first phase. That means now is the time to act – and it starts with a gap assessment. 

Review your current QMS and look at what the FDA will require of you four years from now. What does the gap look like between point A and point B? Think about your resources and how you’re going to manage those gaps. What technology do you need to implement? What staff do you need to hire? What processes are currently missing to be able to deliver the data the FDA requires? If your QMS could be described as “bare bones,” take a look at how to beef it up to meet compliance standards

Most importantly, Quality teams will need to implement an eQMS. Manual quality management can sometimes work at a small scale, but with the inevitable increase in FDA audits and reporting requirements, switching to an electronic system is now a priority for laboratories. Not only does an eQMS support compliance, making it possible to manage documentation, training, corrective and preventive actions (CAPAs), and client complaints, it also eases the burden for your Quality team, keeping everyone fast, efficient, and most importantly, stress-free. 

For more info on what an eQMS actually is, how it works within your current QMS, and how to pick the right one for your team, check out the free eQMS 101 eBook here. 

And if your laboratory is impacted by the FDA’s latest ruling on LDTs, reach out to our team to learn more about what to expect and how to ease the regulatory transition.