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Decoding the FDA’s LDT Regulation: What Lab Leaders Need to Know (Including AP and Molecular Labs)

A recap from NovoPath’s Expert Speaker Series

May 16, 2024

On May 6, 2024, the FDA released it’s Final Rule on Laboratory Diagnostic Tests (LDTs), affecting the lab industry as a whole.

With 10 days, NovoPath hosted an expert-paneled webinar to decode the new rule with hundreds of lab leaders across the United States.

This blog gives an overview of the key takeaways from the event.

Expert Speakers:

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Promise Okeke

CEO, NovoPath

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Sheila Walcoff, JD 

Founder and CEO, Goldbug Strategies

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Jondavid Klipp

President, Laboratory Economics

The Basics: What Are LDTs and How Are They Regulated?

LDTs are tests developed and performed within a single laboratory, often used to diagnose or monitor diseases. Historically, these tests have been regulated by the Centers for Medicare and Medicaid Services (CMS) under the Clinical Laboratory Improvement Amendments (CLIA).

However, the FDA has increasingly asserted its authority over LDTs, citing the need for greater oversight and consistency in test quality.

Key Changes and Deadlines: What Labs Need to Know

One of the most significant changes is the requirement for labs to comply with FDA regulations for LDTs.

This includes following a five-stage process outlined by the FDA, which involves validation, compliance, and submission of documentation. Labs must also adhere to new rules regarding modifications to existing tests, including specimen types and instrument changes.

Implications for Labs and Next Steps

These changes have significant implications for labs, especially those offering complex tests or planning modifications. Labs need to carefully review their test menus, specimen types, and compliance processes to ensure they meet FDA requirements. It’s also important to stay informed about updates and guidance from the FDA to maintain compliance.

Resources and Support for Labs

Navigating these changes can be challenging, but there are resources available to help labs understand and comply with FDA regulations.

The FDA’s website offers some guidance documents and FAQs, while industry organizations and consultants can provide additional support.

Collaborating with experts can help labs navigate the regulatory landscape and ensure they continue to provide high-quality testing services.

Next Steps for Labs

The FDA’s regulation of LDTs represents a significant shift for labs, requiring them to comply with new rules and deadlines.

By understanding the key changes and requirements, labs can prepare themselves for the future of regulatory oversight in the diagnostic testing industry.

Stay informed, collaborate with experts, and take proactive steps to ensure compliance with FDA regulations.

To receive a copy of the webinar deck and receive future, pre-release content from our Expert Series, sign up for our Lab Exclusive mailing list here:

Catch the Webinar Replay

If you missed the webinar, catch a replay of it here:

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