Algorithms that support evidence-based standards of care (e.g., TIMI score for the treatment of Acute Coronary Syndrome) may be exempt from checkpoint reviews. A determination will be made after the algorithm is registered.

As a first step, please register your ABCDS model or tool by completing the registration form and e-mailing it to abcds@duke.edu. The FDA has recently released its Clinical Decision Support Software Guidance, which will help you assess your algorithm-based decision tool before completing the form. The Office of Regulatory Affairs and Quality and the ABCDS Oversight Committee can help answer any questions project teams may have.

This document provides an overview of the ABCDS Oversight process. Our Checkpoint Submission Guide details the material requested at each review.