With the FDA’s new regulation enforcement of laboratory developed tests (LDTs) beginning May 6, 2025, laboratories across the country are preparing for significant changes in how they operate. Most facilities will need to update their documentation systems, enhance staff training protocols, and integrate new quality control measures.
Understanding the LDT regulation phases and their corresponding deadlines is crucial for ensuring your lab’s smooth transition to full compliance. While the laboratory industry faces various administrative and organizational questions that could impact the regulation, the FDA’s commitment to the May 2025 implementation timeline remains firm. By starting early and following a structured implementation plan, facilities can maintain their operational momentum while working toward full compliance with the new regulations.
There are five phases of LDT regulation enforcement that will start in 2025 and continue throughout 2028. Let’s explore each phase and what it means for your laboratory.
Phase 1: Complaint Handling and Initial Quality Requirements (May 2025)
The first phase focuses on establishing robust complaint handling procedures and initial quality system requirements.
Your lab will need to implement processes to handle complaints about your LDTs, whether they come from healthcare providers, patients, or industry partners. Each complaint must be evaluated to determine if it meets FDA reporting criteria and requires further investigation.
When issues arise, your lab must demonstrate that you’ve properly documented the complaint, investigated it thoroughly, and determined whether it needs to be reported to the FDA. This process includes tracking trends to identify potential systemic issues that might require corrective action.
Phase 2: FDA Registration and Compliance (May 2026)
By 2026, laboratories must complete their FDA registration and meet specific compliance requirements.
This phase involves registering your laboratory as a medical device manufacturer with the FDA, which includes paying registration fees and listing all your LDTs as devices. Each test must be properly named and documented.
Additionally, you’ll need to implement labeling requirements that ensure traceability for all listed products. This includes proper identification and tracking systems for your LDTs.
Phase 3: Complete Quality Management System (May 2027)
The third phase requires implementing a comprehensive quality management system. This includes:
- Document control and management review processes.
- Design and testing records maintenance.
- Annual management reviews of quality metrics.
- Internal audit procedures.
- Vendor qualification and management.
- Production controls and consistency measures.
This phase ensures your entire operation follows documented procedures and maintains proper records from test design through production and monitoring in compliance with QMSR.
Phase 4: High-Risk Device Review (November 2027)
Beginning November 6, 2027, laboratories must comply with premarket review requirements for high-risk in vitro diagnostics (IVDs) offered as LDTs. This includes tests that may be classified as Class III devices or those subject to licensure under section 351 of the Public Health Service Act. If you’ve submitted your premarket submission before this deadline, the FDA plans to exercise enforcement discretion during their review period.
Phase 5: Moderate and Low-Risk Device Review (May 2028)
The last LDT regulation deadline is May 6, 2028, when laboratories must comply with premarket review requirements for moderate-risk and low-risk IVDs offered as LDTs that require premarket submissions.
Similar to Phase 4, if you’ve submitted your premarket submission before this deadline, the FDA will exercise enforcement discretion while reviewing your submission.
This phase completes the full implementation of the FDA’s new LDT rule, ensuring all laboratory developed tests, regardless of risk level, meet appropriate safety and effectiveness standards through proper premarket review processes.
What Goes Into Meeting Each Phase
The phased implementation of the FDA’s LDT enforcement provides time to adapt, but don’t underestimate the work involved. Setting up these systems typically requires 120-200 hours initially, plus ongoing maintenance. Each phase builds on previous requirements, creating a comprehensive quality management system.
While these changes may seem intimidating, they’re designed to ensure consistent quality and safety in laboratory testing. Working with experienced consultants can help streamline the process and ensure you meet each deadline with confidence.
Remember, the LDT enforcement discretion phase-out schedule represents when compliance must be complete—not when to begin preparation. Starting early ensures a smoother transition and helps avoid last-minute scrambling to meet requirements.
Navigate LDT Regulation With Confidence
Need help preparing for these changes? Consider working with experienced partners who can guide you through each phase of implementation, ensuring you meet deadlines while maintaining your lab’s efficiency and innovation.
At CMD MedTech, we maintain a comprehensive understanding of the evolving regulatory landscape through active participation in industry forums, regular analysis of FDA guidance updates, and ongoing dialogue with laboratory stakeholders. This commitment to regulatory intelligence allows us to anticipate potential challenges and develop targeted solutions for our laboratory partners.
Our team’s deep expertise in regulatory compliance allows us to translate complex requirements into practical implementation strategies, ensuring our clients remain both compliant and competitive as the industry evolves. Navigate the new LDT rule with confidence–contact us to get started.