What the FDA?
Steve SilvermanInsights on FDA device regulation and the effect on the MedTech community
| Platform |  | Pricing | Only free issues | Publishes | Weekly |
|---|---|---|---|---|---|
| Issues | 62 | Founded | a year ago | Last Issue | 13 days ago |
| Active | |||||
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steveilverman.substack.comLatest Issues
MDUFA VI: Don’t Bank on FDA Hiring
FDA and the device industry negotiated MDUFA VI quickly. The agreement includes FDA hiring goals that industry should track.
What happened?[1]
FDA and industry agreed in principle on MDUFA VI, the next round of device user fees, whic...
What Patients Want – FDA’s Updated PPI Guidance
FDA updated its guidance on how patient views affect device regulation. The guidance is voluntary. Firms that overlook it will wish they hadn’t.
What happened?[1]
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The CNPV Survived Makary. That’s a Big Deal for Device Firms.
Marty Makary created the Commissioner’s National Priority Voucher (CNPV) program. When he got bounced from FDA, folks asked whether the CNPV would follow him out the door. The answer came fast: HHS confirmed that there would be no changes t...
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]
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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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