FDA Shoots Down Bid for Review Exemption on Company’s Radiology AI Devices, Citing Safety Gaps

5 Key Takeaways

• 1

  The FDA denied Harrison.ai's request to bypass premarket review for radiology AI devices, emphasizing the need for safety validation.

• 2

  Harrison.ai sought exemption for various AI tools, including CADx software, arguing that prior 510(k) clearance should allow future bypass.

• 3

  The FDA criticized the proposal's reliance on manufacturer self-monitoring, highlighting the lack of independent evaluation mechanisms.

• 4

  Feedback on the proposal was largely negative, with concerns about patient safety and the immaturity of postmarket AI monitoring.

• 5

  The FDA suggested Predetermined Change Control Plans as a compromise, allowing pre-approval for future AI updates after initial review.