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.
Liverpool confirms Arne Slot as Jurgen Klopp's replacement
I'm an American living in the UK... here's why universal healthcare is not all roses
Suárez throws 7 scoreless innings, Castellanos and Rojas homer in Phillies 8
US announces a new $400 million package of weapons for Ukraine to try to hold off Russian advances
Russian theater director and playwright go on trial over a play authorities say justifies terrorism
Natalie Elphicke says sorry for backing 'naughty Tory' sex attacker ex
Crochet strikes out 11 to help the White Sox beat the Guardians 6
The Flores agreement has protected migrant children for nearly 3 decades. Changes may be coming.
Liverpool confirms Arne Slot as Jurgen Klopp's replacement
Hawaii officials outline efforts to prevent another devastating wildfire ahead of a dry season
Analysis: Larson enters conversation with Verstappen as best drivers in the world
Police arrest 3 suspects in rural California shooting that killed 4 and wounded 7