What the FDA?
Steve SilvermanInsights on FDA device regulation and the effect on the MedTech community
| Platform |  | Pricing | Only free issues | Publishes | Weekly |
|---|---|---|---|---|---|
| Issues | 67 | Founded | a year ago | Last Issue | 11 days ago |
| Active | |||||
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steveilverman.substack.comLatest Issues
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...
The Next FDA Commissioner Matters to Device Firms
Note to readers: What the FDA? won’t publish next Friday, July 10, 2026, and will return on Friday, July 17. This week’s column follows:
FDA needs a new Commissioner and most of the chatter about candidates centers on drugs and biologics....
Does FDA Digital Health Deregulation Survive Makary’s Exit?
In January, then-FDA Commissioner Marty Makary declared that FDA needs to move at “the speed of Silicon Valley.” Within days, FDA loosened its oversight of digital wearables (like health trackers) and AI-enabled clinical decision support so...
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Authors
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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