• Posted April 29, 2024

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

Laboratory tests used by millions of Americans are soon to be classified as medical devices, and as such be regulated by 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 test" (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.

“Laboratory developed 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."

Strengthened FDA oversight will include include agency review of tests before they reach the market, quality system requirements and adverse event reporting and labeling requirements, among other considerations.

There was one glaring exception: Thousands of tests currently marketed prior to these new rules may not have to undergo FDA review, the agency said.

Quality checks and enforcement on those tests will be at the agency's "discretion," the FDA said, since "perceived costs of compliance with such requirements could lead to the widespread loss of access to beneficial [tests] on which patients currently rely."

“Today’s action is a critical step toward helping to ensure the safety and effectiveness of LDTs, while also taking into account other public health considerations, including continued access to critical tests patients rely upon,” said Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health.

The FDA first released a draft form of the new rules last September. According to the Associated Press, private industry was quick to assert that the agency did not have authority to extend oversight in the medical test market.

The American Clinical Laboratory Association (ACLA) told the AP Monday it “has grave concerns about this rule as a matter of both policy and law. The rule will limit access to scores of critical tests, increase health care costs, and undermine innovation in new diagnostics.”

ACLA has as members large testing chains such as Quest Diagnostics and LabCorp, as well as smaller labs and test makers.

More information

Find out more about medical tests at Stanford Health Care.

SOURCES: U.S. Food and Drug Administration, statement, April 29, 2024, Associated Press