FDA’s New Rule on Lab-Developed Tests: A Five-Stage Plan for Stronger Oversight


The U.S. Food and Drug Administration (FDA) is set to transform the landscape of laboratory-developed tests (LDTs) through a new rule designed to increase oversight and ensure the safety and effectiveness of these critical diagnostic tools.

Why the Change?

LDTs, once considered simple in-house tests, have evolved into sophisticated high-volume assays that significantly influence healthcare decisions. The FDA’s move is driven by concerns over the accuracy and reliability of some LDTs. Inaccurate results or misleading claims can severely impact patient care, prompting the need for stricter regulatory control.

The Five-Stage Plan

The FDA’s phased approach to enforcement aims to gradually bring LDTs under stricter regulatory oversight:

Stage 1: Prioritizing Patient Safety (May 6, 2025)

Medical Device Reporting:
Labs must report any adverse events or malfunctions associated with their LDTs, ensuring prompt identification and resolution of safety issues.

Corrections and Removals:
Labs are required to notify the FDA and healthcare providers of any necessary corrections or removals of faulty tests, safeguarding patients from potential harm.

Complaint File Management:
Robust systems must be in place to track and address complaints related to LDTs, facilitating continuous improvement and quality assurance.

Stage 2: Clear Labeling and Regulated Research (May 6, 2026)

Registration and Listing:
Labs must register their establishments and list their LDTs with the FDA, providing transparency and accountability.

Labeling Compliance:
LDTs must adhere to stringent labeling requirements, ensuring accurate and informative communication about the test’s purpose, limitations, and results.

Investigational Use Oversight:
Any LDTs used for research purposes must comply with regulations governing investigational device exemptions (IDEs), protecting research

Stage 3: Quality Systems in Focus (May 6, 2027)

Enhanced Quality Systems:
Labs must implement comprehensive quality systems to ensure consistent and reliable test performance, covering aspects like design controls, supplier management, and risk assessment.

Stage 4: Premarket Review for High-Risk Tests (November 6, 2027)

High-Risk LDTs Under Scrutiny:
LDTs classified as high-risk due to their potential impact on patient safety will undergo rigorous premarket review like other medical devices. This ensures their safety and effectiveness before they reach patients.

Stage 5: Expanding Premarket Review (May 6, 2028)

Moderate and Low-Risk LDTs:
Premarket review requirements will extend to moderate and low-risk LDTs, further strengthening the regulatory framework for all types of laboratory-developed tests.

Balancing Oversight with Access

While the FDA’s increased oversight aims to improve patient safety, it recognizes the need to balance regulation with access to vital diagnostic tools. Certain categories of LDTs, including those used for rare diseases or public health surveillance, will be exempt from some or all requirements.

The Path Forward

This phased approach will allow laboratories time to adapt to the new regulations, ultimately fostering a safer and more reliable landscape for LDTs. The FDA’s goal is to ensure that all patients have access to accurate, safe, and effective diagnostic tests, improving healthcare outcomes for all.

For more information, you can visit the FDA’s official page on LDT regulations.

Additional Resources:

FDA Medical Device Reporting

Investigational Device Exemptions

By keeping abreast of these changes and understanding their implications, laboratories can ensure compliance while continuing to provide essential diagnostic services to patients. The phased implementation timeline allows for a structured transition, emphasizing patient safety and regulatory compliance at every stage.