ACR Leaders Present 23 CPT Codes at RUC Meeting
ACR presented 23 CPT codes at the AMA RUC meeting, offering recommendations across key radiology procedures and preparing for the April 2026 cycle.
Read moreMain Content
FDA Seeks Feedback on Draft AI Device Guidance
Jan. 10, 2025
The U.S. Food and Drug Administration (FDA) seeks public comments on draft guidance it published Jan. 7. Of particular interest to the American College of Radiology® (ACR®) is “Artificial Intelligence (AI)-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.”
The industry guidance outlines a total product lifecycle (TPLC) approach to risk management of AI device software functions, as well as related documentation to support FDA review. It also provides recommendations relevant to transparency and bias mitigation throughout the TPLC, including within the product’s user interface and labelling.
The ACR Informatics Commission and Data Science Institute® (DSI) leadership are reviewing the guidance. The College’s initiatives related to AI are on the DSI website.
Public comments are due to the FDA by April 7.
If you have questions or would like more information about ACR AI/digital health policy, contact Michael Peters, ACR Senior Director, Government Affairs.
