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. |
NHL announces Bodyarmor as its new sports drink, replacing BioSteelSt James's Place paid £213K to HMRC for my inheritance tax billWorld is not doing enough to protect coral reefs, UN envoy saysDraft report says Missouri's House speaker stymied ethics investigation into his spendingChina's spy agency encourages people to see spies everywhere — Radio Free AsiaDonors pledge $630 million for conflict2 men exchange gunfire at Flint bus station, leaving 1 in critical conditionBank of America accused of religious and political 'discrimination' by 'deBank of America accused of religious and political 'discrimination' by 'deJustice Thomas returns to Supreme Court after 1