FDA brings lab tests under federal oversight in bid to improve accuracy and safety
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.
Related articles
What's next for Iran after death of its president in crash?
JERUSALEM (AP) — The death of Iran’s president is unlikely to lead to any immediate changes in Iran’2024-05-21Trump reveals exactly what he'll do if he loses the 2024 presidential election
Donald Trump has revealed what he will do in November if he loses the 2024 presidential election and2024-05-21Hamas says to halt Gaza ceasefire negotiations if Israel attacks Rafah
The Palestinian Islamic Movement (Hamas) said on Wednesday that the ceasefire negotiations with Isra2024-05-21China promoting rapid development of commercial space industry: CNSA
This aerial photo taken on Dec. 29, 2023 shows the No. 1 launch pad of Hainan commercial spacecraft2024-05-21Children are evacuated from school 'during an exam' after threat made via email
Children have been evacuated from a school with Year 11 students told to leave mid-exam after a thre2024-05-21- This photo taken during a helicopter aerial tour on March 21, 2024 shows Wuzhizhou Island in Sanya,2024-05-21
atest comment