This week on Trying to Keep Up, Allison Komiyama and Michael Nilo are joined by regulatory strategist and former FDA reviewer Allison Kumar to unpack the FDA news dump nobody had time to read.

The trio dives into FDA’s rollout of QMSR, updates to compliance and audit procedures, the launch of the TEMPO Pilot program for digital health technologies, and what recent hiring activity could mean for review timelines and agency capacity. They also unpack the latest MDUFA performance data, PMA publication delays, evolving real-world evidence expectations, and why device-specific guidances may finally be getting more useful.

Along the way, they discuss the new SQUID PMA approval, CDRH Learn updates, eSTAR 6.1 changes, and the growing importance of AI, cybersecurity, and chronic disease technologies at FDA.

Plus: regulatory jokes, dental device trauma, Super Bowl gambling talk, and Allison Komiyama’s accidental lip-filler era.

Key Topics Covered

• FDA QMSR implementation and compliance program updates
• Tempo pilot program for digital health devices
• MDUFA performance metrics and review timelines
• FDA reviewer hiring and return-to-office discussions
• Real-world evidence in De Novos and PMAs
• eSTAR 6.1 updates for De Novo submissions
• Cybersecurity and software guidance updates
• SQUID PMA approval for chronic subdural hematoma treatment
• Device-specific guidance documents and blood pressure device guidance
• CDRH annual report highlights

Links

• Brendan O’Leary MDUFA analysis
• CDRH Learn
• FDA eSTAR Program
• FDA QMSR Resources
• FDA RWE Guidance