In this episode of BRight Minds in Healthcare Delivery, host Eric Tower speaks with Tom Sundlof, a former attorney in the FDA's Office of the Chief Counsel and a recent addition to Blank Rome, about the shifting regulatory landscape at the U.S. Food and Drug Administration ("FDA") and what it means for healthcare innovation in 2026.
Tom shares insights from more than a decade at the FDA, discussing recent leadership turnover, evolving agency priorities, and key initiatives such as the Commissioner's National Priority Voucher program. He also examines how political pressure, transparency concerns, and internal agency dynamics are influencing drug and device review processes.
A central focus of the conversation is the rise of AI‑enabled medical devices, digital health tools, and remote patient monitoring. Tom explains how these technologies are challenging traditional regulatory frameworks, where the lines are drawn between regulated medical devices and unregulated software, and why early engagement with the FDA is critical for innovators.
The episode offers a practical, real‑world look at how companies can navigate FDA oversight, balance innovation with patient safety, and position their products for regulatory and commercial success in an increasingly complex healthcare environment.
In his practice, Tom provide clients with counsel on regulatory, compliance, and enforcement matters for medical devices, combination products, and other FDA-regulated industries.
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