Health policy (Amsterdam, Netherlands) · 2026
Comparative analysis of in vitro diagnostic medical devices and laboratory-developed tests: Insights from global regulation.
СтатьяСравнительное исследованиеОбзорПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Choi Jiwon, Jeon Sohye, Jung Jiyun, Lim Sooyeon, Nam Mihyang, Oh KyeongTaek
Аннотация
BACKGROUND: Oversight of in vitro diagnostic medical devices (IVD-MDs; synonymous with IVDs) and laboratory-developed tests (LDTs) remains fragmented across jurisdictions, posing challenges for global market access and patient safety.
OBJECTIVE: This study compares LDT regulatory frameworks in major regions to identify gaps and opportunities for international convergence.
METHODS: A comparative review was conducted across five jurisdictions-the IMDRF, United States (US), European Union (EU), Japan, and Korea-using official regulatory documents, guidelines, and recent updates.
RESULTS: The EU's transition from the In Vitro Diagnostic Directive (IVDD) to the In Vitro Diagnostic Regulation (IVDR) established a risk-based classification and stricter requirements for LDTs. Conversely, the US Food and Drug Administration (FDA) rescinded its 2024 Final Rule on LDTs in 2025 following a federal court ruling, thereby restoring primary authority to CLIA. Japan and Korea regulate LDTs under broader laboratory accreditation systems without dedicated legislation. The IMDRF has not yet issued binding guidance on LDT oversight.
CONCLUSIONS: LDT regulation worldwide remains non-harmonized. The newly issued ISO 5649:2024 provides internationally recognized specifications for LDT design, validation, and quality management, supporting future efforts toward global regulatory convergence and patient safety assurance.
OBJECTIVE: This study compares LDT regulatory frameworks in major regions to identify gaps and opportunities for international convergence.
METHODS: A comparative review was conducted across five jurisdictions-the IMDRF, United States (US), European Union (EU), Japan, and Korea-using official regulatory documents, guidelines, and recent updates.
RESULTS: The EU's transition from the In Vitro Diagnostic Directive (IVDD) to the In Vitro Diagnostic Regulation (IVDR) established a risk-based classification and stricter requirements for LDTs. Conversely, the US Food and Drug Administration (FDA) rescinded its 2024 Final Rule on LDTs in 2025 following a federal court ruling, thereby restoring primary authority to CLIA. Japan and Korea regulate LDTs under broader laboratory accreditation systems without dedicated legislation. The IMDRF has not yet issued binding guidance on LDT oversight.
CONCLUSIONS: LDT regulation worldwide remains non-harmonized. The newly issued ISO 5649:2024 provides internationally recognized specifications for LDT design, validation, and quality management, supporting future efforts toward global regulatory convergence and patient safety assurance.