Laboratory Developed Tests (LDTs) are critical for diagnosing rare diseases and addressing unmet clinical needs. They are developed, manufactured, and used within a single licensed clinical laboratory for purposes of clinical...more
5/30/2025
/ Asia Pacific ,
Australia ,
Centers for Medicare & Medicaid Services (CMS) ,
China ,
CLIA ,
Food and Drug Administration (FDA) ,
Government Agencies ,
Laboratory Developed Tests ,
Medical Devices ,
Regulatory Reform ,
Singapore
Regulation of artificial intelligence (AI) in Asia Pacific remains nascent, mostly governed by existing regulatory frameworks designed for other technologies and products. It’s a work in progress. AI techniques – machine...more