FDA change plans in radiology AI - Takeaways - MDSpire
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FDA change plans in radiology AI

Investigators examined adoption and public documentation of change control plans for FDA-cleared radiology AI devices.

  • By

  • Kathryn Wighton

  • September 16, 2026

  • 3 min

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  • 1

    Adoption of Predetermined Change Control Plans increased among radiology AI devices after FDA guidance was issued.

  • 2

    A systematic review evaluated FDA-cleared radiology AI/ML devices from 2015 to 2025 for PCCP use and public documentation transparency.

  • 3

    Among 1,394 FDA-listed AI/ML submissions, 1,080 (78%) were in radiology, with 99% cleared through the 510(k) pathway.

  • 4

    Public documentation for PCCP devices had a mean score of 5 on an 8-point rubric, indicating incomplete transparency.

  • 5

    The analysis highlighted limitations due to reliance on publicly available data and inconsistencies in FDA databases.

Original Source(s)

FDA change plans in radiology AI

  • by Kathryn Wighton

  • September 16, 2026

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