Association for Molecular Pathology files lawsuit against FDA to challenge final rule on regulation for laboratory developed testing procedures

Updated Model Signage for the Emergency Medical Treatment and Labor Act

Medicare Program; Transitional Coverage for Emerging Technologies

REVISED: Final Rule - Clinical Laboratory Improvement Amendments of 1988 (CLIA) Proficiency Testing - Analytes and Acceptable Performance Final Rule (CMS-3355-F)

CDRH announces partnership to develop new methods to accelerate diagnostic device development for underserved populations

Association for Diagnostics & Laboratory Medicine (formerly AACC) survey finds that FDA’s final laboratory developed tests rule will impede the fight against the U.S.’s drug epidemic

CMS preparing to close program that addressed Medicare funding issues resulting from Change Healthcare cyber-attack