FDA Finalizes New Regulations For Laboratory-Developed Tests

The AP (4/29, Perrone) reports, “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 FDA regulation “will gradually phase in oversight of new tests developed by laboratories, a multibillion-dollar industry that regulators say poses growing risks to Americans.” The aim “is to ensure that new tests for cancer, heart disease, COVID-19, genetic conditions and many other illnesses are safe, accurate and reliable.” Reuters (4/29, Sunny) reports, “Under the new rules, these tests would be required to meet the same requirements as other diagnostic tests from medical device makers, including the FDA’s review of their applications and the reporting of adverse events.” The Hill (4/29, Choi) reports that in the past, such tests “were typically manufactured in small volumes to diagnose rare diseases. At the time, the FDA’s rationale for not enforcing regulations on these tests were that they were low-risk and were employed for a small patient population.” However, the laboratory-developed tests “have grown in use over the years, as have concerns over their lack of regulatory oversight.” The Wall Street Journal (4/29, Whyte) also reports.