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Open Access Academic Papers from Research Square

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Systematic Review posted

Evaluating Transparency of Predetermined Change Control Plans in FDA-Cleared Radiology AI Devices: A Systematic Scoping Review

Ketan Dayma, Palak Patel, Kenneth Hildreth, Tamara Jamaspishvili

Importance: Adoption of FDA-cleared AI/ML-enabled devices is rising, led by Radiology, and FDA is adapting to a newer framework of Predetermined Change Control Plan (PCCP) to enable controlled post-ma...

Research Square 2026-04-15 rs-9411603
Artificial Intelligence Radiology Predetermined Change Control Plan (PCCP) Post-Market Surveillance Software as a Medical Device (SaMD)
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