What the FDA?
Steve SilvermanInsights on FDA device regulation and the effect on the MedTech community
| Platform |  | Pricing | Only free issues | Publishes | Weekly |
|---|---|---|---|---|---|
| Issues | 69 | Founded | 2 years ago | Last Issue | 8 days ago |
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steveilverman.substack.comLatest Issues
Dumb & Dumber: FDA Doubles Down on OII “Simple Reform”
What happened?[1]
FDA announced earlier this month that it was moving forward with OII redesign plans. I reviewed those plans, part of FDA’s “Simple Reform” program, in an earlier column.
I was sure my concerns would end Simple Refor...
CDRH’s Human Factors Guidance Is a Premarket Checkpoint[1]
What happened?[2]
In May, CDRH finalized its guidance, Content of Human Factors [HF] Information in Medical Device Marketing Submissions (HF Guidance), replacing the 2022 draft. HF has long been a murky corner in premarket review. CDRH has...
Conventional Devices Deserve CDRH Attention
Looking at CDRH press, it’s hard to remember that not all devices are digital. CDRH’s 2025 annual report details digital-health milestones and the report’s “looking ahead to 2026” section highlights AI and next-generation technology. Plus,...
Broken Clocks Aren’t Always Right Twice a Day
Asking how long it takes FDA to close a device recall gets a wince before an answer. That wince is earned. A 2025 GAO report confirms what device firms know: FDA’s three-month recall closure target is more suggestion than deadline, the back...
FDA Says the Trains Are Running on Time. At CDRH, They’re Late.
Former FDA Commissioner Marty Makary talked about timely FDA processes, promising last July to meet device user-fee targets. But his words don’t stand up against CDRH reality. Calendar-day timelines have grown (a lot), raising questions abo...
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The writers behind this newsletter.
Steve Silverman is the President of The Silverman Group, a consultancy that serves medical product companies on regulatory, strategy, and policy issues. Steve’s experience includes extensive time in senior FDA roles.
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