FDA's “Valentine’s Day Massacre”
This week on Trying to Keep Up, Allison Komiyama and Michael Nilo are joined by regulatory consultant Monica Fahrenholtz, who shares a firsthand account of the unprecedented disruption inside FDA during the past year—from mass layoffs to return-to-office chaos and the ripple effects still being felt across the MedTech ecosystem.
Monica walks through what it was actually like inside FDA during the “Valentine’s Day massacre,” including abrupt terminations, communication breakdowns, and how review teams continued hitting regulatory deadlines despite extreme instability. The conversation highlights the resilience of FDA reviewers and the operational risks companies should still be planning for today.
The team also breaks down key regulatory updates:
A new De Novo clearance for LifeVac, an anti-choking device now formally entering the regulated space
A PMA approval for the Synergy Disc®, an expanding cervical disc replacement system
Updates from MDUFA VI negotiations, including potential improvements to the De Novo process
Ongoing questions around FDA’s use of AI tools following security concerns and policy shifts
New and updated FDA guidance and safety communications, including choking response protocols
As always, the episode opens with a round of (very questionable) jokes—because sometimes the only way to keep up is to laugh through it.
Key Topics Covered
Inside the FDA layoffs and organizational disruption
Impact of staffing changes on review timelines and industry expectations
De Novo pathway updates and process improvements
LifeVac anti-choking device clearance and regulatory implications
Synergy Disc® PMA approval and clinical positioning
MDUFA VI negotiation insights (De Novo meetings, staffing transparency)
FDA AI tool usage and security concerns
Updated FDA safety communications and digital health resources
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