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.
Brazil replaces injured goalkeeper Ederson in Copa America squad
Sylvester Stallone breaks silence amid Tulsa King 'toxic workplace' scandal
Senate opposition leaves South Carolina energy bill with listless future
Wild moment elephant marauds through small town in Montana after breaking loose from circus
Liverpool confirms Arne Slot as Jurgen Klopp's replacement
NPR suspends whistleblower who exposed taxpayer
Rose Byrne looks unrecognisable with a bleached blonde beehive wig on set of latest movie Tow
Barry Keoghan sports a Burberry bandana on his face as he playfully poses with Stormzy at Coachella
Young Boys seals 6th Swiss soccer league title in 7 years after rallying from firing coach Wicky
Wisconsin man pleads not guilty to neglect in disappearance of boy