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.
Celebrity birthdays for the week of May 26
Report: Chinese swimmers were allowed to compete at Tokyo Olympics despite positive doping tests
Rihanna giggles as she does an impressive British accent at her FENTY X Puma event in London
Soar, slide, splash? It’s skiers’ choice as spring’s wacky pond skimming tradition returns
The Rolling Stones' US tour 'set to feature iconic popstar after setlist leak'
Chinese scientist awarded for groundbreaking work in transplantation, cellular therapy
China prepares to launch relay satellite Queqiao
Everybody may love Raymond, but Ray Romano loves Peter Boyle
China had over 1.26 mln UAVs by end of 2023
Ship that caused Baltimore bridge collapse has been refloated
Braves' Travis d'Arnaud hits first 3 HRs of season, including go