Open-Source Diabetes App Beats FDA-Approved Systems — SkimNews
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- Dana Goldman, a health economist with type 1 diabetes for over 30 years, says open-source software manages her glucose monitor and insulin pump better than the FDA-approved systems she was upgraded to every five years — running free on her iPhone.
- Lowell Schiller, former head of policy at the FDA, acknowledged the agency has modernized some frameworks (exempting lower-risk apps, expanding software updates without new review) but remains constrained by a 50-year-old statute designed for traditional devices.
- A pilot program launched during the first Trump administration aimed to pre-certify software developers' quality processes, letting them innovate within an approved framework — but it could not be fully implemented under existing FDA statutory authority.
- Congress will reauthorize the FDA's next five-year user fee cycle next January; user fees fund roughly half the agency's human medical product budget, and the negotiated agreements could carry statutory reforms enabling better review of medical and open-source software.
- Goldman warns that without action, patients will increasingly turn to homegrown code, creating a bifurcated software environment unfair to both patients and FDA-regulated device manufacturers who cannot innovate at the same pace or scale.
Why it matters: The FDA user fee reauthorization cycle funds roughly half the agency's human medical product budget and opens a rare window for statutory reform. Without congressional action, the FDA's 50-year-old device statute will keep regulators outmatched by software development speed — pushing more patients toward unvetted open-source alternatives while FDA-cleared device manufacturers are stuck competing on outdated timelines.
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