How the FDA can catch up with medical software innovation | STAT
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“It is no longer possible to ask the FDA to keep pace with software development by doing the same reviews faster,” writes Dana Goldman.
By Dana P. Goldman Aug. 4, 2026 Goldman is founding director of the USC Schaeffer Institute for Public Policy and Government Service. I have had type 1 diabetes for more than 30 years, which I manage using a glucose monitor connected to an insulin pump. About every five years, I would get upgraded pumps and sensors that were approved by the Food and Drug Administration and covered by my insurance. Still, my glucose control slowly deteriorated. One day, my physician encouraged me to explore new, open-source software that better manages the sensor and pump system. This new code — written…
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