FDA Software Rules Outdated, Diabetes Patient Argues
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- Dana Goldman, a USC health economist with type 1 diabetes for over 30 years, says FDA-approved insulin pump and sensor systems left his glucose control deteriorating until he switched to free, open-source software running on his iPhone.
- The open-source code was written by users dissatisfied with the FDA-regulated app and fine-tunes his insulin delivery in ways no approved system could; he now meets previously elusive glucose guidelines.
- Former FDA policy head Lowell Schiller told Goldman the agency has modernized its frameworks — exempting lower-risk apps and expanding which updates skip review — but is constrained by a 50-year-old statute written for hardware, not software.
- A pilot program from the first Trump administration sought to pre-certify software developers' processes and quality systems rather than reviewing each product, but the FDA lacked statutory authority to fully implement it.
- Congress reauthorizes the FDA's five-year user fee cycle next January, with industry fees funding roughly half of the agency's human medical product budget — a window Goldman argues could carry statutory reforms enabling faster review of medical and open-source software.
- Goldman warns that without reform, patients will keep scouring the internet for homegrown code, creating a 'bifurcated software environment' that disadvantages both patients and regulated manufacturers.
Why it matters: With the FDA's user-fee reauthorization due in Congress by January, the article makes a concrete case for embedding software-specific statutory reform into those negotiations. The author — himself a patient relying on unregulated code — argues the current framework disadvantages FDA-regulated manufacturers who can't iterate at software speed, while roughly half the FDA's medical product budget sits in the fee cycle that Congress is about to renegotiate.
