After years of jostling with industry, failed legislative efforts, and some false starts, the US Food and Drug Administration (FDA) has unveiled its plan to bring laboratory developed tests (LDTs) into its regulatory fold over the next four years.
The much-anticipated final rule amends the agency’s regulations to explicitly treat in vitro diagnostics (IVDs), including tests made by laboratories, as medical devices and offers a phased approach to regulating such tests.
“Today, we’re taking an important step forward in assuring patients, providers, and the public have access to safe, effective tests that they can trust,” FDA Commissioner Robert Califf said during a press briefing on Monday. “LDTs are being used more widely than ever before – from newborn screening, to predicting a person’s risk of cancer, or aiding and diagnosing heart disease and Alzheimer’s disease… However, the risks associated with most modern LDTs are much greater than the LDTs used when FDA’s enforcement discretion approach was adopted many years ago.”…
