The Food and Drug Administration announced a controversial final rule aimed at improving the safety of laboratory diagnostic tests following years of controversy about the agency’s oversight of the products, including during the COVID-19 pandemic.

“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 Califf told reporters on Monday. “The agency cannot stand by while Americans continue to rely on results of these tests without assurance that they work.”