Tens of thousands of medical exams are now under federal oversight

The Food and Drug Administration (FDA) is revising long-standing rules to bring laboratory tests under the same jurisdiction as other tests, which the agency says will help ensure better safety and effectiveness.

Since 1976, the FDA has not imposed legal requirements on most laboratory-developed tests (LDT) due to the Medical Device Amendments. Generally speaking, this means that requirements such as good manufacturing practices, pre-market reviews before use in patients and reporting of adverse events were not applied.

LDTs are diagnostic tests made and used in a single laboratory. As the FDA noted in its rule on Monday, LDTs ​​were typically manufactured in small volumes to diagnose rare diseases. At the time, the FDA’s justification for not enforcing regulations on these tests was that they were low risk and were used for a small patient population.

But the use of LDTs ​​has increased over the years, as have concerns about their lack of regulatory oversight. Common LDTs ​​today include COVID-19 testing, blood level testing, and drug abuse testing. While LDTs ​​in the 1970s were performed by specialized laboratory personnel, today’s tests now utilize high-tech instrumentation and software to generate results.

“Today’s LDTs ​​are also more commonly manufactured with instruments or other components not legally marketed for clinical use and are more often used to inform or direct critical treatment decisions, to broadly screen for common illnesses, to predict personal risk from developing certain diseases, and to diagnose serious medical conditions such as cancer and heart disease,” the FDA said in its final rule on LDTs.

The FDA cited these factors in announcing the change.

“LDTs are being used more widely than ever before – for use in neonatal screenings, to help predict a person’s cancer risk, or to help diagnose heart disease and Alzheimer’s. The agency cannot stand by while Americans continue to trust the results of these tests without guarantees that they work,” said FDA Commissioner Robert M. Califf. in a statement.

The announcement was well received by health groups.

The American Cancer Society called the change “a positive step toward ensuring uniform review of all tests intended for the same purpose.”

The change also generated some pushback, however. Sen. Bill Cassidy (R-La.), ranking member of the Senate Health, Education, Labor and Pensions Committee, criticized the decision.

“The FDA does not have the authority to unilaterally increase its regulatory jurisdiction. This rule will harm access to essential laboratory tests, increase health care costs and ultimately harm patients,” Cassidy said in a statement.

“During the pandemic, we have seen how excessive government interference and bureaucracy delays life-saving care for Americans. Congress needs to take action to clarify the regulatory framework for diagnostic tests.”