Comment from Rubrum Advising
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Summary: Rubrum Advising, a healthcare consulting firm, supports the FDA's pilot program for AI-enabled optimization of early-phase clinical trials. They specifically recommend expanding the program's scope to include a separate pilot for medical device early feasibility studies (EFS) to better leverage AI for iterative device development and safety monitoring.
Please find attached Rubrum Advising's comments in response to Docket Number: FDA-2026-N-4390