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Scientific Reviewer, Office of InVitro Diagnostics and Radiological Health (OIR) at CDRH, FDA
Automated Insulin Delivery Systems and the Regulatory Pathway: Interactive Strategies for Clinical Studies to Premarket Submission
To promote innovation and access to automated insulin dosing (AID) systems, FDA has been active in helping developers and manufacturers navigate the regulatory process. FDA recognizes the rapid pace of innovation in the diabetes devices space, and our participation in the optimization of validation plans, clinical studies, and post market evaluations has accelerated the availability of safe and effective AID devices.