What the FDA?
Steve SilvermanInsights on FDA device regulation and the effect on the MedTech community
| Platform |  | Pricing | Only free issues | Publishes | Weekly |
|---|---|---|---|---|---|
| Issues | 72 | Founded | 2 years ago | Last Issue | 11 days ago |
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steveilverman.substack.comLatest Issues
The Device Tariff Window Is Open
What happened?[1]
Much of the device industry tariff talk last year focused on the International Emergency Economic Powers Act (IEEPA). That changed in February when the Supreme Court ruled that the IEEPA doesn’t authorize the Preside...
FDA Is Getting Smart on GenAI Devices
FDA signals in an August 18 discussion paper that it’s getting up to speed on GenAI. Before it picks a formal framework, FDA is seeking input on how it should evaluate risk, premarket performance, and postmarket monitoring for GenAI devices...
Third Time’s Not Always the Charm. Device Firms Must Push for a Competent FDA Commissioner.
I know: a barrage of articles cover Dr. Heidi Overton’s nomination for FDA Commissioner. She may not make it through the nomination process, but device firms still should consider their role in picking the next Commissioner, including how t...
Dumb & Dumber: FDA Doubles Down on OII “Simple Reform”
What happened?[1]
FDA announced earlier this month that it was moving forward with OII redesign plans. I reviewed those plans, part of FDA’s “Simple Reform” program, in an earlier column.
I was sure my concerns would end Simple Refor...
CDRH’s Human Factors Guidance Is a Premarket Checkpoint[1]
What happened?[2]
In May, CDRH finalized its guidance, Content of Human Factors [HF] Information in Medical Device Marketing Submissions (HF Guidance), replacing the 2022 draft. HF has long been a murky corner in premarket review. CDRH has...
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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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