Suresh Sarojani

Comment on Docket FDA-2026-N-7874-0001
Submitted by Suresh Sarojani , October 19, 2026

A Competency-Based Approach for Premarket Evaluation of GenAI-Enabled Devices
1.FDA’s proposed approach of selecting device benchmarking elements based on devices intended use and risk profile is scalable across use scenarios and clinical workflows. Aligning benchmarking requirements and plans across PCCP, Premarket, Clinical Validation and Post Market is critical. A well development risk management plan , Controls and Benchmarking dedicated for GenAI device software functions should be required.
2.Benchmarking of various elements need to be reviewed based on the deployment – A chatbot, a suggested next best action agent, autonomous long running clinical support agent – all should have benchmarking elements aligned to the scope of operation
3.While some elements of Device Benchmarking is can be evaluated and calibrated( like clinical knowledge on a specific area, in depth understanding on device operating model) , it may be difficult to reproduce and calibrate many of the benchmarking elements. These need to identified for post market monitoring,
4.Independent Benchmark maintainers and Evaluators are required both internally and externally to the Tech provider and clinical systems. Cross sharing of benchmarking methodology and building a strong Benchmarking ecosystem need to promoted