New FDA lab tests regulations announced

FDA lab tests overview: 

• Who: The U.S. Food and Drug Administration (FDA) announced new rules to regulate lab tests. 
• Why: The FDA says that lab tests are not providing accurate results, making them dangerous to the general public.
• Where: The FDA lab tests rule applies across the United States.

The U.S. Food and Drug Administration (FDA) announced new rules to regulate lab tests to improve accuracy and accountability in the process.

The FDA announced that laboratory diagnostic tests (LDTs) should be considered devices under the Federal Food, Drug, and Cosmetic Act and increase scrutiny of those tests.

Over the next four years, the FDA will phase out its policy of general enforcement of LDTs, and targeted enforcement will begin, the FDA says.

“LDTs are being used more widely than ever before – for use in newborn screening, to help predict a person’s risk of cancer, or aid in diagnosing heart disease and Alzheimer’s,” FDA Commissioner Robert M. Califf said in a statement. “The agency cannot stand by while Americans continue to rely on results of these tests without assurance that they work. The final rule announced today aims to provide crucial oversight of these tests to help ensure that important health care decisions are made based on test results that patients and health care providers can trust.”

New FDA lab tests policy necessary because of increased use, agency says

Some existing lab tests are inaccurate, unsafe and ineffective, the FDA says. These lab tests are used for purposes such as cancer risk assessment, COVID-19 diagnosis, rare disease management and more.

“Without greater oversight of the safety and effectiveness of LDTs, patients may be more likely to initiate unnecessary treatment, or delay or forego proper treatment based on inaccurate test results or tests promoted with false or misleading claims,” the FDA says. “This could result in harm, including worsening illness or death, as well as unnecessarily increase health care costs.”

The previous lab test rules were put in place when lab tests were lower risk, sold in smaller volumes and used for specialized reasons. Now, testing is used for a wider and more diverse array of purposes, with some large laboratories working with patients across the country using high tech equipment to lab test in large volumes. That increase has led to the need for higher scrutiny on the accuracy and safety of that testing, the FDA says.

The FDA announced in February that manufacturers nationwide are no longer using PFAS food packaging.

Have you had an inaccurate lab test result? Let us know in the comments.

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