HeyJaredWhat the FDA?
Insights on FDA device regulation and the effect on the MedTech community
- Indexed issues, last 90 days
- 11
- Latest publication
- Sep 25, 2026
- Audience
- Checking…
- Earliest in this view
- Jul 3, 2026
Latest issues
What HHS Consolidation Means for CDRH Independence (opens the original)
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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 the device center. But that stability is bumping up against HHS-led changes: efforts to pull FDA leadership close to Secretary Kennedy and an FDA Commissioner nominee picked because she’s a “<a href="https://www.
MAHA Comes for Medical Devices (opens the original)
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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 wearables “a key to the MAHA agenda” and predicted that every American would be wearing one within four years. HHS <a href="https://www-ak-ms.foxnews.com/health/rfk-j
The Device Tariff Window Is Open (opens the original)
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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 President to impose tariffs. The Court reasoned that a tariff is a tax, the Constitution reserves taxing power to Congress, and IEEPA
FDA Is Getting Smart on GenAI Devices (opens the original)
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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. But two companies didn’t wait for FDA to finish its homework. UpDoc[1] and RecovryAI are testing the agency’s appetite for chatbot-style dev
Third Time’s Not Always the Charm. Device Firms Must Push for a Competent FDA Commissioner. (opens the original)
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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 they’re communicating expectations.What happened?
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