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. |
Khloe Kardashian shows off her curves in formKathryn Newton is ultra chic in headIOC imposes 15SZA calls out Australians over 'disgusting' act at her Melbourne showBritney Spears' sister Jamie Lynn Spears isn't bothered by Toxic singer branding her a 'b***hFormer Nickelodeon star Victoria Justice, 31, opens up about filming her first sex sceneTroyes fans and players throw flares at each other after 2ndSudan: UN warns that Darfur risks starvation and death if aid isn't allowed inFormer Nickelodeon star Victoria Justice, 31, opens up about filming her first sex sceneCheers and flames as Orthodox worshipers greet the ancient ceremony of the 'Holy Fire'