5 Key Takeaways

• 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.