What the FDA?
Steve SilvermanInsights on FDA device regulation and the effect on the MedTech community
| Platform |  | Pricing | Only free issues | Publishes | Weekly |
|---|---|---|---|---|---|
| Issues | 59 | Founded | a year ago | Last Issue | 12 days ago |
| Active | |||||
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steveilverman.substack.comLatest Issues
Do FDA’s New Leaders Know About Devices and Does It Matter?
Views on Kyle Diamantas’s appointment as FDA’s acting Commissioner focus heavily on drugs and biologics and less on medical devices. That’s understandable given the dramatic circumstances of his appointment. But device questions remain: doe...
FDA Is Using AI to Review Your Devices. Should You Be Worried?
There’s a new reviewer checking your CDRH submission. You didn’t meet during the Pre-Sub, the reviewer won’t show up on the review team roster, and it may cite studies that don’t exist. Welcome to Elsa.
What happened?[1]
Thanks for readin...
FDA’s One-Day Inspection Assessment Plan: Window Dressing for a Damaged Program
Writing about inspections days after Marty Makary got fired feels like reporting the weather on the day the Hindenburg crashed. Instead of adding to the pile of excellent coverage, I’ll address one of Makary’s final announcements: a pilot p...
Device Firms May Want FDA Review (Even If They Don’t Need It)
In January, FDA published its revised General Wellness guidance, granting enforcement discretion to digital products that measure physiologic parameters (like heart rate variability and blood oxygen saturation). For many firms, that means n...
Credit Where It’s Due: The RAPID Coverage Pathway
Note to readers: when I saw the RAPID announcement last week, I thought, “that’s a good subject for my column. Readers will be interested and the topic won’t get too much coverage.” A week later, everybody’s written about RAPID (this mornin...
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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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