What the FDA?
Steve SilvermanInsights on FDA device regulation and the effect on the MedTech community
| Platform |  | Pricing | Only free issues | Publishes | Weekly |
|---|---|---|---|---|---|
| Issues | 75 | Founded | 2 years ago | Last Issue | 10 days ago |
| Active | |||||
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The FDA–SEC Pact
What happened?[1]
On August 31, the FDA and the SEC signed a memorandum of understanding (MOU) to share information about FDA-regulated products and the companies that sell them.
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What HHS Consolidation Means for CDRH Independence
For much of 2026, CDRH has been a calm spot in a chaotic agency. While FDA’s drug and biologics centers churned through acting directors and the Commissioner’s office turned over after Marty Makary’s ouster, Michelle Tarver has steadily led...
MAHA Comes for Medical Devices
The MAHA agenda is usually a story about seed oils, vaccines, and food dye. But over the past year, MAHA’s chronic-disease focus has become a device story too.
What happened?[1]
Appearing before Congress last year, RFK Jr. called wea...
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...
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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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