What the FDA?
Steve SilvermanInsights on FDA device regulation and the effect on the MedTech community
| Platform |  | Pricing | Only free issues | Publishes | Weekly |
|---|---|---|---|---|---|
| Issues | 29 | Subscribers | Read | steveilverman.substack.com |
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Latest Issues
Recent posts by this newsletter. Browse the email archive.
CDRH's FY2026 Guidance List: Read Between the Lines
CDRH just released its guidance priority list for fiscal year 2026 (FY26), saying it will finalize guidance on real-world evidence (RWE) and predetermined change control plans (PCCPs). But what does this list actually tell us about what CDR...
Trump’s “America First” Policy Threatens Device Manufacturing and Global Supply Chains
Trump’s drug reshoring push is an alarm bell for device firms. While Trump didn’t target devices, his America First stance means that device companies must be ready for similar treatment. Smart firms will get ahead of the reshoring push bef...
FDA’s Warning Letter Surge – the Real Deal or Much Ado About Nothing?
FDA is ramping up warning letters. As its recent drug-advertising blitz shows, FDA is ready to act, publicly and aggressively, to send enforcement messages. And the push goes beyond drug makers; there’s been a spike in device warning letter...
Is that a bandwagon? Let me on!
Today's column is a lightly edited version of an article I co-wrote with the awesome Eric Henry, focused on the Quality Management System Regulation (QMSR). The article highlights parts of the QMSR that MedTech firms should pay attention to...
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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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