AI/MLMay 2026
What 'Predetermined Change Control' Actually Means for Your AI Model
A practical read on how the FDA's PCCP framework changes the way adaptive AI/ML diagnostics get authorized — and maintained over time.
Writing
Notes on regulation, AI, and building well.
AllFDAAI/MLStartupsLeadership
FDAApril 2026
De Novo Is Not a Fallback. Treat It Like a Strategy.
Why the De Novo pathway deserves a seat at the table from day one, not just when 510(k) options run out.
StartupsMarch 2026
Building a Regulatory Function Before You Think You Need One
The case for hiring regulatory leadership earlier than instinct says you should — and what that role should own first.
AI/MLJanuary 2026
Reading an AI Diagnostic's Validation Study Like a Regulator
The questions I ask before I ever look at a sensitivity and specificity table.
LeadershipNovember 2025
The Regulatory Leader's Job Is Translation, Not Gatekeeping
Reframing regulatory affairs as a function that unblocks good work, not one that exists to say no.
FDASeptember 2025
Cybersecurity Documentation Nobody Reads Until They Have To
What an FDA reviewer is actually looking for in your §524B submission, and where most teams under-build.