More Medical Lab Tests Will Soon Face Federal Scrutiny, FDA Says

MONDAY, April 29, 2024 (HealthDay News) — Laboratory tests used by millions of Americans are soon to be classified as medical devices, and as such be regulated by the U.S. Food and Drug Administration, the agency announced Monday.

The new rule does not apply to tests and kits made by big medical device manufacturers — those already face FDA review.

Instead, the agency is widening its oversight to include thousands of tests made by labs, large hospitals and universities, so-called “laboratory developed tests” (LTDs) or in vitro diagnostic products (IVDs).

“The FDA announced a final rule today amending the FDA’s regulations to make explicit that IVDs are devices under the Federal Food, Drug and Cosmetic Act,” the agency said in a statement.

FDA Commissioner Dr. Robert Califf said the change, phased in over the next four years, is necessary to protect Americans from inflated claims about the accuracy of LDT results or inaccurate tests.

“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. The agency cannot stand by while Americans continue to rely on results of these tests without assurance that they work,” Califf said in an agency news release. “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.”

The FDA said that LDTs have had lax oversight because in decades past many were “lower risk, small volume and used for specialized needs.”

That”s changed in recent years.

“Now, many LDTs are used more widely, for a larger and more diverse population, with large laboratories accepting specimens from across the country,” the agency said. “LDTs also increasingly rely on high-tech instrumentation and software, are performed in large volumes, and are used more frequently to help guide critical health care decisions.”

The FDA said patients have already been harmed from a variety of flawed lab tests, including those for COVID-19, cancer or assessing cancer risk.

The recent case of blood tests marketed by Theranos, helmed by now-disgraced and imprisoned CEO Elizabeth Holmes, is just one high-profile example. Those tests promised to quickly and accurately spot disease using just a drop of blood, but they failed to deliver on that promise.

“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 said. “This could result in harm, including worsening illness or death, as well as unnecessarily increase health care costs.”