Letter to FDA Commissioner Dr. Martin A. Makary RE: regulation of laboratory developed tests

We write to you regarding the District Court for the Eastern District of Texas’s March 31 decision in an industry-initiated lawsuit challenging FDA’s authority to regulate Laboratory Developed Tests (LDTs). As you know, the court ruled, in its primary finding, that LDTs are services, not devices, thereby setting aside a final rule that had been in the works at FDA for years. We expect the Agency is concerned about an opinion that removes authority from FDA over an important subset of medical products and erodes the Agency’s authority to ensure safe and effective diagnostics are on the market. View the resource below to keep reading.

Can you trust that lab-developed test? Here’s what to know

Laboratory-developed tests (LDTs), a $20B unregulated industry, pose risks with unreliable results. Learn more about these tests and the FDA's new final rule.

FDA’s Laboratory-Developed Tests Final Rule: District Court Amicus Brief

CSPI filed an amicus brief in support of FDA’s Final Rule strengthening oversight over Laboratory-Developed Tests (LDTs).

Laboratory-developed tests final rule: public health benefits outweigh the costs

The clinical laboratory industry has loudly protested the Food and Drug Administration's final rule to oversee laboratory-developed tests, claiming the costs do not justify the benefits. FDA's economic impact analysis of the rule suggests otherwise. Download our fact sheet to discover how much the public stands to benefit from this rule.

Laboratory-developed tests: FDA moves to close loophole

Laboratory-developed tests have proliferated in volume and complexity. In 2024, the FDA released a rule that mandates LDTs to comply with current FDA requirements.

Peter's Memo: Can you trust that lab-developed test?

When the FDA began regulating lab-developed tests, they were used on few patients. But LDTs are now used to diagnose or determine treatment for many diseases.

FDA finalizes much-needed rule to regulate laboratory-developed tests

Letter to the Office of Management and Budget regarding FDA's final rule on laboratory-developed tests

The undersigned organizations support the regulation of laboratory-developed tests (LDTs) by the Food and Drug Administration (FDA) in order to ensure that patients and doctors are getting results that are clinically meaningful and accurate. LDTs are diagnostic tests that are developed and used in a single laboratory. They have become increasingly important in clinical practice but have evaded regulation by FDA for decades. LDTs that are inaccurate or not supported by scientific evidence put patients at risk for adverse health outcomes and increase healthcare costs. Click "View Letter" below to keep reading.

House panel to discuss FDA proposal to regulate lab-developed tests

Lab-developed tests: Everything you need to know

Lab-developed tests can detect anything from COVID-19 to genetic diseases. But there is virtually no oversight of these devices. Here's what to know.