Understanding the FDA’s proposed rule on laboratory-developed tests (LDTs)

Lucy Hilton Date published: Nov 22, 23

The U.S. Food and Drug Administration (FDA) has announced a proposed rule aimed at ensuring the safety and effectiveness of laboratory developed tests (LDTs). These tests play a crucial role in healthcare, with their use becoming increasingly prevalent in making important medical decisions.

Key points:

• FDA proposes to modify the definition of “in vitro diagnostic products” in 21 CFR Part 809.3 to expressly include laboratory-developed tests.
• The change would require all IVDs, including LDTs, to comply fully with FDA’s medical device regulatory requirements, including applicable premarket review requirements.
• FDA proposes a phased end to its current policy of enforcement discretion for LDTs, with regulatory requirements becoming applicable in five stages over four years and premarket review requirements falling in the final two stages.
• Certain specified tests, such as forensic tests and human leukocyte antigen tests, would be excluded from the new enhanced oversight.
• Comments on the Proposed Rule must be submitted by December 4, 2023.

LDTs are in vitro diagnostic products (IVDs) intended for clinical use that are designed, manufactured, and used within a single laboratory which meets specific laboratory requirements. IVDs are commonly used in the collection, preparation, and examination of human body specimens such as blood, saliva, or tissue. IVDs, including LDTs, can measure or detect substances, analytes, or markers in the body to provide valuable information about a patient's health. This includes diagnosing, monitoring, or determining treatment for various diseases and conditions.

The proposed rule aims to clarify that IVDs are devices under the Federal Food, Drug, and Cosmetic Act, even when the manufacturer is a laboratory. Additionally, the FDA is proposing a policy of increased oversight for LDTs through a phaseout of their previous approach of enforcement discretion.

While in the past, the FDA has generally not enforced applicable requirements for most LDTs, the risks associated with most modern LDTs are much greater than those used decades ago. These risks far outweigh those of older tests and could potentially result in harm to patients. The agency is concerned that some tests may be providing inaccurate test results or that they do not perform as well as FDA-authorized tests and others complying with FDA requirements.

For instance, some patients could be over or under treated for heart disease, while others with cancer could be exposed to inappropriate therapies or miss out on effective treatments altogether. There have also been cases of misdiagnosis of rare diseases and Alzheimer's Disease due to inaccurate LDTs.

Overall, the proposed rule and increased oversight of LDTs aim to prioritize patient safety and ensure that these tests provide accurate results to aid in effective medical decisions.

What could this mean for your speed-to-market?

If the proposed rule by the FDA regarding LDTs comes into effect, it would require all IVDs, including LDTs, to fully comply with the FDA’s medical device regulatory requirements, including applicable premarket review requirements. This potential change in regulation highlights the need for companies to be agile to changes. It could even be seen as a great opportunity. Companies who can efficiently and successfully exercise their compliance without any pushback can get ahead of the game while others are still adjusting to the changes.

As companies and laboratories navigate the proposed changes from the FDA regarding LDTs, having a robust and comprehensive review process in place is crucial. This is where Ideagen PleaseReview can play a vital role in helping organizations comply with the new regulations. With its document review capabilities, including version control and audit trail, Ideagen PleaseReview ensures that all necessary requirements are met and documented.

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