What the FDA?
Steve SilvermanInsights on FDA device regulation and the effect on the MedTech community
| Platform |  | Pricing | Only free issues | Publishes | Weekly |
|---|---|---|---|---|---|
| Issues | 42 | Subscribers | Read | steveilverman.substack.com |
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Latest Issues
Recent posts by this newsletter. Browse the email archive.
What FDA’s 2025 Warning Letter Surge Means for Contract Manufacturer Oversight
FDA is hammering device sponsor for improperly supervising contract manufacturing organizations (CMOs). Sponsors who reply “we didn’t know” when they learn of CMO quality failures earn warning letters. But sponsors can avoid this result by ...
FDA’s Digital Health Policy Pivot
Commissioner Makary announced his digital health deregulatory push in Las Vegas, promising to move at “the speed of Silicon Valley.” On January 6, FDA delivered with updated guidances on Clinical Decision Support (CDS) software and General ...
Total Recall
That’s a cheesy title, but who doesn’t love Total Recall?! It’s one of Schwarzenegger’s best parts, right after Conan the Barbarian and before Governor of California.
Sometimes less is more. In Marty Makary’s case, it’s less.
Sorry about this week’s title; ad hominem attacks are petty. But FDA Commissioner Makary closed 2025 with an action so absurd that I can’t leave it alone.
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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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