Will FDA's LDT Final Rule Bring "Balance To The (IVD) Force"?

The U.S. Food and Drug Administration (FDA or the Agency) issued a Final Rule on May 6, 2024 (89 FR 37286) that will, over the next four years, radically alter the landscape for laboratory developed tests (LDTs). This action follows FDA's Proposed Rule issued on October 3, 2023 (88 FR 68006, Oct. 3, 2023). Unfortunately, the calendar prevented publication in the Federal Register on Saturday May the 4th, but the Final Rule nonetheless puts an exclamation point on the Agency's decades-long goal to "correct the imbalance" between in vitro diagnostics (IVDs) marketed outside a laboratory and those IVDs manufactured by a laboratory.

Bringing "Balance" to FDA's In Vitro Diagnostic (en)Force(ment)