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.
Georgia Republicans choose Amy Kremer, organizer of pro
Arsenal crash OUT of the Champions League after losing to Harry Kane's Bayern Munich in the quarter
Banker's son, 22, on trial for 'drowning alcoholic dad in baptism
Leonardo DiCaprio tipped to play Frank Sinatra in new Martin Scorsese biopic
UK Conservatives suspend lawmaker as sleaze allegations swirl over possible misuse of party funds
Copenhagen and Paris mayors exchange lessons learned after huge fires destroy landmarks
Google announces another round of layoffs as part of 'large scale' restructuring
Insider Q&A: CIA's chief technologist's cautious embrace of generative AI
NFL draft has potential to set a record for most players on offense selected in the first round