Artificial intelligence in endoscopic ultrasound: Clinical translation of a prediction, navigation, and diagnosis framework

Table 2 Comparison of regulatory approaches to artificial intelligence-assisted endoscopic ultrasound in foreign countries

Feature	United States (FDA)	European Union (MDR/IVDR + AI Act)
Regulatory core	Function-based (what the software does) tiered regulation	Device risk + AI system risk dual matrix regulation.
Classification logic	CADt → CADe → CADx → CADa, with increasing risk	Class I, IIa, IIb, III (device risk), plus the AI Act’s “high-risk” category for most medical AI
Primary pathways	510(k) (substantial equivalence), De Novo (novel low-moderate risk), PMA (high risk)	Self-certification (class I low risk), notified body conformity assessment (class IIa and above)
Adaptability	Predetermined change control plans allow for iterative updates to cleared algorithms within defined bounds without new submission	Update processes under regulations are stricter; significant software changes typically require re-assessment/notification to the notified body
Clinical evidence	Emphasizes prospective, multi-center clinical trials to demonstrate safety and effectiveness	Emphasizes clinical evaluation with comprehensive technical documentation and performance validation, aligned with GDPR
Transparency	Requires disclosure of algorithm performance	The AI act emphasizes transparency, requiring high-risk AI systems to provide clear usage information and ensure outputs are interpretable and overseen by humans
Process flowcharts	AI medical device concept → determine intended use and function: CADt, CADe, CADx, or CADa → assign FDA risk class → generate clinical and technical evidence → submit to FDA for review → FDA approval clearance → post-market surveillance	Medical AI product → determine device risk class per MDR/IVDR → determine AI system risk level per AI act (typically “high-risk”) → comply with both sets of requirements → undergo conformity Assessment by a notified body (for class IIa and above) → obtain CE marking

This table summarizes the fundamental differences between the United States Food and Drug Administration and European Union [Medical Device Regulation/In Vitro Diagnostic Regulation + artificial intelligence (AI) act] regulatory approaches for AI in endoscopic ultrasound. Understanding these distinctions in regulatory philosophy, classification logic, and approval pathways is crucial for the global clinical translation and integration of AI-enhanced endoscopic ultrasound devices. FDA: Food and Drug Administration; MDR: Medical Device Regulation; IVDR: In Vitro Diagnostic Regulation; AI: Artificial intelligence; 510(k): Premarket notification; PMA: Premarket approval; De Novo: Pathway for novel, low-to-moderate risk devices; GDPR: General data protection regulation; Notified Body: Independent organization designated by an European Union country to assess conformity of medical devices; CADt: Computer-aided detection for triage; CADe: Computer-aided detection; CADx: Computer-aided diagnosis; CADa: CompUTER-aIDED aUTONOmous diagnosis; CE: European conformity.