Important Update for Laboratories Offering Laboratory Developed Tests (LDTs): Time to Prepare for New FDA Regulations!  

In May 2024, the FDA finalized a rule that will bring significant changes to the regulation of Laboratory Developed Tests (LDTs)*, marking an end to decades of enforcement discretion. Under this new framework, laboratories that manufacture nonexempt LDTs will be required to comply with medical device regulations, phased in gradually over the next four years. Stage One of compliance is fast approaching, with key deadlines and requirements set for May 6, 2025. 

*LDTs are in vitro diagnostic products (IVDs) that are intended for clinical use and are designed, manufactured, and used within a single laboratory that is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and meets the regulatory requirements under CLIA to perform high complexity testing. 

Here’s what laboratories need to know and do to stay compliant with Stage One: 

🔹 Medical Device Reporting (MDR) Requirements: 
By May 6, 2025, laboratories must comply with MDR regulations, which require reporting to the FDA any adverse events where an LDT may have caused or contributed to a death or serious injury, or if an LDT malfunctions in a way that could lead to harm. Even potential issues (e.g., design flaws or user errors) must be reported. Once a laboratory becomes aware of such an event, a report must be submitted within 30 days (or 5 days for urgent public health risks). Make sure your team establishes robust processes to identify, document, and report these events on time via the FDA’s Electronic Submissions Gateway. 

🔹 Correction and Removal Reporting Requirements: 
Labs will also need to comply with the FDA’s correction and removal requirements. Any corrective actions (such as repairs, modifications, or removals) taken to address health risks or unlawful activities related to an LDT must be reported to the FDA within 10 working days. Even if no report is necessary, detailed records must still be kept of all corrections and removals for FDA inspection. Now is the time to set up your system for tracking, documenting, and reporting these activities. 

🔹 Quality System Complaint Files: 
The FDA also requires that laboratories maintain formal Quality System complaint files. This means you must have a designated unit to manage and review complaints about your LDTs, ensuring that all complaints—both oral and written—are properly documented and evaluated. If a complaint relates to a potential adverse event, it may trigger additional MDR reporting. Make sure your complaint-handling procedures are solid, with thorough documentation and trend analysis capabilities to ensure compliance during FDA inspections. 

Who Needs to Comply? 

The FDA’s rule applies to most laboratories offering nonexempt LDTs. Some exceptions exist, such as: 

1. LDTs similar to those used in 1976, performed manually in a single CLIA-certified laboratory. 

2. LDTs used for human leukocyte antigen (HLA) testing in transplant activities. 

3. Forensic tests for law enforcement purposes. 

4. LDTs manufactured and used within the Department of Defense or Veterans Health Administration. 

However, if your laboratory offers any LDTs outside of these categories, it’s time to ensure compliance with the FDA’s Stage One requirements. 

Why Prepare Now? 

While there are ongoing legal challenges to the FDA’s authority over LDTs, including lawsuits from the American Clinical Laboratory Association (ACLA) and other groups, labs should not wait for these cases to be resolved before acting. It is unclear if the courts will rule before the May 2025 deadline, and waiting could lead to last-minute infrastructure investments and rushed compliance efforts. 

Setting up the necessary infrastructure for adverse event reporting, correction and removal systems, and complaint handling processes will take time. Start assessing your laboratory’s current capabilities now and develop an action plan to ensure you’re ready to meet these new regulatory obligations. 

Next Steps: 

1. Assess compliance needs: Evaluate whether your LDTs are exempt or subject to Stage One requirements. 

2. Implement reporting systems: Set up the processes and technology needed to meet MDR, correction, and removal obligations. 

3. Establish complaint procedures: Designate and train a formal complaint unit, and develop comprehensive documentation practices. 

4. Stay informed: Keep an eye on the evolving legal landscape and any updates from the FDA or courts that could impact your compliance timeline. 

The FDA’s rule represents a major shift for the industry, and the deadlines are approaching fast. Now is the time to get ahead of the curve and ensure your laboratory is fully compliant by May 6, 2025.  

The ADRES team is here to support you in ensuring your laboratory achieves full compliance with the latest FDA regulations.