HDE Spotlight, AI Missteps, and FDA Trust Gaps
Was it really a quiet week at the FDA?
In this episode of Trying to Keep Up, Allison Komiyama and Michael Nilo are joined by Hal Stowe (Eurofins Biopharma Services) to break down a week that looked slow on the surface—but delivered meaningful updates across regulatory pathways, policy, and industry trends.
The team starts with a new Humanitarian Device Exemption (HDE) for the River™ Stent System and uses it as a lens to explain how orphan pathways work, when they make sense, and where they create long-term strategic constraints.
From there, the conversation shifts to a Federal Register update impacting PMA data expectations—especially around pediatric populations—and what it signals about FDA’s evolving priorities. They connect this to broader momentum around innovation, access, and pressure to support underrepresented patient groups.
The discussion then moves into emerging risks and friction points:
A warning letter tied to AI-generated quality systems—and why validation still matters
Ongoing gaps in clinical trial transparency and reporting compliance
Increasing complexity in combination products, particularly device–drug integration
A growing disconnect between industry experience and public trust in the FDA
They also highlight forward-looking developments, including the NIH HEAL Initiative’s focus on device research and continued efforts to shift regulatory burden toward post-market data collection.
As always, the episode blends practical insight with candid perspective—and a few jokes—while unpacking what these changes mean for MedTech teams navigating regulatory strategy today.
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