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).

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Title: 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).
Authors: Shanmugam, Umamaheswari1 (AUTHOR), Rajendran, Mohan Kumar2 (AUTHOR), Natarajan, Jawahar1 (AUTHOR), Karri, Veera Venkata Satyanarayana Reddy1,2 (AUTHOR)
Source: Journal of Clinical Medicine. Mar2026, Vol. 15 Issue 5, p1937. 21p.
Database: Academic Search Ultimate
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ISSN:20770383
DOI:10.3390/jcm15051937