Clinical Trial Design and Regulatory Requirements for Artificial Intelligence as a Medical Device: A PRISMA-ScR-Guided Scoping Review of Global Guidance and Evidence (2017-2025).
PMID: 41827353 ·
Umamaheswari Shanmugam, Mohan Kumar Rajendran, Jawahar Natarajan, Veera Venkata Satyanarayana Reddy Karri
JournalJournal of clinical medicine
Year
PMID41827353
Abstract
Background: Artificial Intelligence as a Medical Device (AIaMD) introduces regulatory, methodological, ethical, and clinical challenges that are not fully addressed by traditional device trial frameworks. Given rapidly evolving and jurisdiction-specific guidance, a consolidated mapping of trial design expectations and regulatory requirements is needed. Objective: To map regulatory requirements and clinical trial design approaches for AIaMD across major jurisdictions and to identify key methodolo
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