FDA Seeking to Bring Lab-Developed Tests Under Its Authority

A leading laboratory association has criticized the move, claiming that the agency is overstepping its authority.

The U.S. Food and Drug Administration (FDA) in White Oak, Md., on June 5, 2023. Madalina Vasiliu/The Epoch Times

The U.S. Food and Drug Administration (FDA) proposed a rule that would bring laboratory-developed tests under its regulatory authority, a decision that the Trump administration opposed during the COVID-19 pandemic when the agency wanted to regulate COVID-19 tests.

Lab-developed tests (LDTs) are services developed by clinical labs and hospitals. Such testing services aren’t commercially manufactured and marketed. Instead, they’re designed, manufactured, and used within a single laboratory, intended for clinical use.