Navigating the FDA’s Proposed Rule on Lab Developed Tests

by | Jan 19, 2024 | 510k, FDA, Medical Devices, Regulatory, Validation

In a landscape where diagnostic testing plays a pivotal role in healthcare, the FDA has proposed a significant rule that could reshape the regulation of Lab Developed Tests (LDTs). This move is part of the FDA’s broader efforts to modernize and enhance oversight of diagnostic tests, ensuring their safety and effectiveness. In this blog, we’ll delve into the key aspects of the FDA’s proposed rule on LDTs and its potential impact on the landscape of diagnostic testing.

Lab Developed Tests, or LDTs, are diagnostic tests designed, manufactured, and used within a single laboratory. Historically, these tests have been subject to less stringent regulatory oversight compared to commercial, FDA-approved diagnostics. However, the FDA’s proposed rule seeks to bring LDTs under a more comprehensive regulatory framework.

The FDA’s proposed rule on LDTs aims to address several critical aspects including the pre-market review process for LDTs. Under the proposed rule, LDTs with the highest risk would undergo pre-market review, requiring laboratories to submit evidence of analytical and clinical validity. This aligns with the FDA’s goal of ensuring that diagnostic tests are reliable and accurate before reaching patients.

Additionally, certain LDTs will have to comply with 21 CFR 820, most notably 21 CFR 820.30 for Design Controls. This means that the labs that develop the tests will have to create and maintain a Design History File (DHF) for the products, which would be a drastic new requirement. This proposed rule would introduce Design Controls to many labs for the first time, so they will also be responsible for developing procedural governance and infrastructure for a Design Controls process, in addition to retroactively developing a DHF for their LDT.

Laboratories would be given a phased timeline to come into compliance with the new regulations, with higher-risk LDTs facing earlier deadlines. This approach is designed to provide laboratories with the necessary time to adjust their practices and infrastructure.

The FDA’s move to regulate LDTs more closely has sparked discussions and debates within the healthcare and diagnostics community. While proponents argue that increased oversight will enhance patient safety and ensure test accuracy, critics express concerns about potential barriers to innovation and the burden on laboratories to comply with additional regulatory requirements.

The FDA’s proposed rule on Lab Developed Tests reflects a strategic effort to modernize the regulatory framework for diagnostic testing. As the rule undergoes further consideration and potential revisions, stakeholders in the healthcare industry will closely monitor its implications on patient care, innovation, and the broader landscape of diagnostic testing. If you have an LDT, its important to begin considering how this rule will impact you. EMMA International’s team of experts can help you get started now, so you are ready when the rule comes into full effect. Call us at 248-987-4497 or email to learn more!

FDA (October 2023) FDA’s Proposed Rule Regarding Laboratory Developed Tests retrieved from:

Emma International

Emma International

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