The FDA has scrapped a rule that would have allowed the agency to regulate lab-developed tests as medical devices.
Under the rule, the FDA would have phased in oversight of laboratory-developed tests over a four-year period. LDTs are tests designed, manufactured and used within a single clinical laboratory, often in hospital and academic medical center labs. However, on March 31, the U.S. District Court for the Eastern District of Texas ruled the FDA had overstepped its authority and vacated the rule.
The agency’s move comes after a national trade group, the American Clinical Laboratory Association, filed a lawsuit May 29, 2024, against the FDA, arguing that Congress did not grant the agency the authority to regulate professional testing laboratory services.
As a result, the FDA updated its regulations to remove the changes made in 2024, returning to the original version of the rules.
The original rule was expected to cost the healthcare industry more than $1.3 billion each year and by vacating it, the FDA estimates around $1.5 billion in yearly cost savings.
