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FDA Rule Change Sees Laboratory Developed Tests Regulated as Medical Devices

FDA Rule Change Sees Laboratory Developed Tests Regulated as Medical Devices: How AF Pharma Can Help You Enter the US Market


In a significant move aimed at enhancing the oversight of laboratory-developed tests (LDTs), the US Food and Drug Administration (FDA) has proposed a new rule that will classify these tests as medical devices. This change marks a substantial shift in the FDA's approach to LDTs, emphasizing the importance of ensuring their accuracy and reliability, especially given their growing role in modern medical care. In short, FDA sees Laboratory Developed Tests Regulated as Medical Devices.

The Proposed Rule

The FDA's proposed rule seeks to amend its regulations to explicitly classify In Vitro Diagnostic Products (IVDs) as medical devices under the Federal Food, Drug, and Cosmetic Act when the manufacturer of the IVD is a laboratory. This means that laboratories producing diagnostic tests will need to adhere to the same regulatory standards as traditional medical device manufacturers.

Under this rule change, the FDA also plans to phase out its general enforcement discretion approach regarding LDTs. In the past, many LDTs have operated with relatively little regulatory oversight. However, the proposed policy aims to provide greater scrutiny to ensure the accuracy and validity of these tests.

The Rationale

FDA Commissioner Robert M. Califf underscored the importance of this regulatory change, stating that "a growing number of clinical diagnostic tests are being offered as laboratory-developed tests without assurance that they work." He emphasized that the stakes are higher than ever as these tests are increasingly used to guide critical treatment decisions.

According to the Centers for Disease Control and Prevention (CDC), a staggering 70% of medical decisions today rely on laboratory test results. With such a significant impact on public health, it is crucial to guarantee the accuracy and reliability of these tests.

Concerns and Implications

The FDA's concerns are valid and pressing. Inaccurate test results can lead to patients receiving unnecessary treatment or, conversely, delaying or avoiding proper treatment, potentially causing harm. The consequences of flawed LDTs can be profound, affecting individual patient outcomes and public health as a whole.

The regulatory change aims to address these concerns by holding laboratory-developed tests to the same rigorous standards as other medical devices. This shift is expected to lead to improved quality control, enhanced validation processes, and a more thorough assessment of the accuracy of LDTs before they reach patients.

How AF Pharma Can Help

For manufacturers seeking to enter the US market with laboratory-developed tests, navigating the complex FDA regulatory landscape can be daunting. This is where AF Pharma comes into play as a valuable partner. AF Pharma can act as your US Agent, providing essential support and guidance in understanding and complying with FDA regulations. Laboratory Developed Tests Regulated as Medical Devices, can be handled by your US Agent.

As your US Agent, AF Pharma can assist you in:

  1. Regulatory Compliance: Ensuring that your laboratory-developed tests meet all FDA requirements and standards.

  2. Quality Control: Implementing robust quality control measures to enhance the accuracy and reliability of your tests.

  3. Submission Assistance: Helping you with the submission process and interacting with the FDA on your behalf.

  4. Market Entry Strategy: Developing a comprehensive market entry strategy to successfully introduce your tests into the US healthcare market.


The FDA's proposed rule change to classify Laboratory Developed Tests (LDTs) as medical devices reflects the evolving landscape of diagnostic testing and the need for increased oversight. With the growing reliance on LDTs in clinical decision-making, ensuring their accuracy and reliability is paramount to safeguarding public health.

While the FDA's intentions are clear, the implementation of these regulations will undoubtedly require collaboration and cooperation between regulatory bodies, laboratories, and healthcare providers. With AF Pharma as your US Agent, you can navigate this regulatory landscape with confidence, ensuring that your laboratory-developed tests meet the highest standards and can successfully enter the US market. Together, we can enhance the accuracy of diagnostic testing, improve patient outcomes, and uphold the highest standards of healthcare.

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