FDA Town Hall, New De Novo, and the Reality of “Trying”
In this episode of Trying to Keep Up, Allison Komiyama and Michael Nilo are joined by Jim “SugarJimmy” Kleinedler (Medtronic) for a fast-paced, unfiltered conversation on the latest developments in regulatory affairs.
The team kicks things off with a look at a newly cleared De Novo device designed for aortic graft explant procedures—unpacking what it does, why it matters, and how it fits into the broader regulatory landscape.
From there, Jim shares key takeaways from the FDA Town Hall in Minneapolis, including agency priorities, breakout session discussions, and one consistent theme: the industry’s push for greater transparency—especially around common deficiencies and review trends.
They also dig into:
The current state of the TAP program and shifting CMS reimbursement dynamics
Real-world evidence and how FDA expectations continue to evolve
Updates and challenges with the MDDT program and regulatory tools
UDI system expansion and its potential to reshape post-market data
FDA enforcement around ClinicalTrials.gov reporting
Ongoing hiring challenges at the FDA—and what it means for industry
The conversation wraps with thoughts on digital health, AI guidance, and what’s next for companies trying to navigate an increasingly complex regulatory environment.
It’s equal parts insight and reality check—because no one is fully keeping up.
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