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.
Independent UN experts urge Yemen’s Houthis to free detained Baha'i followers
7 Decades Later, Girl Admitted to Grandfather's Alma Mater
Helping Design China's First Large Passenger Aircraft
China's Chen, Lian win golds at diving World Cup in Berlin
Jon Wysocki dead at 53: Staind drummer passes away
The Making of China's Olympic Mascots
Across China: Never Too Late! 66
Graduate Walks the Line, and Her Video Goes Viral
Feature: Chinese Athletes Engage in Fight Against COVID