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. |
Nine injured in incident involving 'corrosive substance' in London, police sayREVEALED: The worst airports in the USSupermarket facial recognition trial: Rotorua mother’s ‘discrimination’ ordealHurricanes Poua won't be allowed to repeat haka criticising governmentOn Your Side: Survey reveals many college students carry creditEye watering amount of money for south Auckland roading project, cyclists sayGovernment unveils plan to fastMinistry of Education explains why it has hired so many new staffHong Kong venue axes live concert by proChina tells Biden to reverse 'dangerous practice' on Taiwan world politics