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.

Laboratory-developed tests: the need for regulation

The FDA has the authority to review medical devices, including lab-developed tests. However, to date FDA has not used this authority to regulate LDTs, allowing the devices to flow freely onto the market without premarket approval.