WASHINGTON (AP) — Makers of medical tests that have long escaped government oversight will have about four years to show that their new offerings deliver accurate results, under a government rule vigorously opposed by the testing industry. The regulation finalized Monday by the Food and Drug Administration will gradually phase in oversight of new tests developed by laboratories, a multibillion-dollar industry that regulators say poses growing risks to Americans. The goal is to ensure that new tests for cancer, heart disease, COVID-19, genetic conditions and many other illnesses are safe, accurate and reliable. “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,” said FDA commissioner Robert Califf, in a release. |
California has a multibillionKansas' governor vetoes a bill for extending child support to fetusesIs this the best value safari in Africa? This flyBEL MOONEY IMAGINES: Am I addicted to attentionWill Power and Josef Newgarden begin Indy quests by adapting to new strategists and engineersMeghan and Harry take Nigeria by storm as they pose for fun selfiesCrochet strikes out 11 to help the White Sox beat the Guardians 6How West Virginia's first transgender elected official is influencing local politicsU.S. House votes to kill motion to remove Speaker Mike JohnsonDear Caroline: My dad has dementia and no longer recognises me or my mother