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.
Cambodia's famed Angkor attracts nearly 540,000 int'l tourists in first 9 months
1 killed, 11 more people hurt in shooting in New Orleans
Online city tours entertain journalists home and abroad at Beijing 2022
Kate Hudson hits the stage to debut songs from her new album Glorious at star
Jenna Bush Hager admits she LOST one of her eight
Displaced Lebanese long for home as Hezbollah
US citizen arrested in Moscow on drug charges appears in court
Cruise worker 'murders newborn son on board ship': Shocked co
Marcos says Duterte struck ‘secret’ deal with Beijing on South China Sea — Radio Free Asia
Britain's new bonkers EV: Callum Skye is an £80k electric buggy built in Warwickshire
China: An active participant in promoting human rights within the framework of global governance