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.
Election 2024: Biden and Trump bypassed the Commission on Presidential Debates
Tianjin's cruise tourism industry set for post
Amazing International Fashions Integrated with Traditional Chinese Cultural Elements
Community's 'Guardian Angel' Helps Residents Live Better Lives
Why US Catholics are planning pilgrimages in communities across the nation
Lonesome Kane fighting Bayern's path back to success
Providing Heartwarming Services to Children
Promoting Thriftiness, Ending Food Waste
Liverpool confirms Arne Slot as Jurgen Klopp's replacement
More civilians die in Ukraine as analysts warn that delays in US aid will hamper Kyiv's forces
Investigators return to Long Island home of Gilgo Beach serial killing suspect
Overseas Returnee Inherits, Revitalizes Traditional Craft