The Food and Drug Administration (FDA) is revising long-standing rules to place laboratory tests under the same jurisdiction as other testing, which the agency says will help ensure better safety and efficacy.
Since 1976, the FDA has not enforced legal requirements on most laboratory developed tests (LDT) due to the Medical Device Amendments. Generally speaking, this has meant that requirements such as good manufacturing practices, premarket reviews prior to use in patients and adverse event reporting has not been enforced.
LDTs are diagnostic tests that are made and used within a single laboratory. As the FDA noted in its rule Monday, LDTs were typically manufactured in small volumes to diagnose rare diseases. At the time, the FDA’s rationale for not enforcing regulations on these tests were that they were low-risk and were employed for a small patient population.
But LDTs have grown in use over the years, as have concerns over their lack of regulatory oversight. Common LDTs today include tests for COVID-19, blood level tests and tests for drug abuse. While LDTs in the ’70’s were carried out by laboratory personnel with expertise, current-day tests now use 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 widely screen for common diseases, to predict personal risk of 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 when announcing the change.
“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,” FDA Commissioner Robert M. Califf said in a statement.
The announcement was welcomed 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 move also drew some blowback, however. Sen. Bill Cassidy (R-La.), ranking member of the Senate Committee on Health, Education, Labor and Pensions, blasted the decision.
“The FDA does not have the authority to unilaterally increase its regulatory jurisdiction. This rule will undermine access to essential laboratory tests, increase health care costs, and ultimately harm patients,” Cassidy said in a statement.
“During the pandemic, we saw how too much government interference and red tape delays lifesaving care to Americans. Congress needs to take action to clarify the regulatory structure for diagnostic tests.”