What the FDA?
Steve SilvermanInsights on FDA device regulation and the effect on the MedTech community
| Platform |  | Pricing | Only free issues | Publishes | Weekly |
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| Issues | 77 | Founded | 2 years ago | Last Issue | 6 days ago |
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steveilverman.substack.comLatest Issues
FDA’s Transparency Roadmap Includes Devices
The biggest commitments in FDA’s recent Transparency Roadmap – announcing applications, publishing rejection letters, and releasing study reports – target drugs, not devices. Device firms should still pay attention. Parts of the roadmap cov...
FDA Wants Its Advisory Committees Back. Device Firms Should Want That Too.
Former FDA Commissioner Makary called advisory committees bureaucratic, conflicted, and expensive, and he largely stopped convening them. When he wanted outside input, he turned instead to handpicked groups that met without conflict screeni...
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...
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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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