This week on Trying to Keep Up, Allison Komiyama and Michael Nilo welcome Mike Ryan, former FDA Deputy Office Director for the Office of Regulatory Programs (ORP) and current consultant at ELIQUENT Life Sciences, for an inside look at some of FDA's biggest regulatory initiatives.

Together, they discuss the proposed MDUFA VI changes, including shorter 510(k) review goals, new pre-submission fees, focused follow-up Q-Subs, De Novo introductory meetings, and what these proposals could mean for both reviewers and industry.

The conversation also covers FDA's announcement of the first participant in the TEMPO Digital Health Pilot, newly authorized and breakthrough devices, and the growing role of AI in orthopedics and diagnostics. Mike shares perspectives from more than two decades at FDA, offering insight into how review teams think, why some regulatory programs succeed, and where innovation can sometimes outpace policy. The episode wraps up with a look at emerging home health technologies, including smarter pulse oximeters and passive patient monitoring devices that could reshape care outside the hospital.

Additional topics include:

• Stryker's SportSuite Vision Software De Novo authorization

• TorEx Lung Perfusion System PMA

• Breakthrough Devices for multi-cancer screening and meniscus replacement

• The evolving value of FDA's Breakthrough Devices Program

• FDA's Voluntary Improvement Program (VIP) and Accreditation Scheme for Conformity Assessment (ASCA) initiatives

• Human Factors Town Hall highlights

• AI-enabled surgical navigation and diagnostics

• Home healthcare and passive monitoring technologies

Links

• Kalshi Opens Betting Market for Pharmaceutical Trials and FDA Decisions

• Register for the FDA’s public meeting on MDUFA VI