US lawmakers introduced a bill to update CLIA oversight for laboratory-developed tests, aiming to restore more structured governance following a 2025 court decision that positioned LDTs as professional services rather than FDA-regulated medical devices. The proposed Enhancing CLIA Act of 2026 would task CMS with creating an LDT database covering performance characteristics and validation information and allow labs to submit tests for voluntary third-party review confirming analytic and clinical validity. It also calls for centralized error reporting and clarifies that LDTs remain professional services under CLIA. The bill’s framing centers on transparency and modernization without “duplicative and burdensome” regulatory requirements that could restrict patient access. Clinical laboratories and industry groups are likely to treat the approach as a middle path between full FDA device oversight and current patchwork compliance. For biotech and diagnostics developers, the proposal signals a continued push toward standardized evidence expectations and traceability as LDTs increasingly compete with commercially validated CDx platforms.