This week on Trying to Keep Up, Allison Komiyama and Michael Nilo are joined by regulatory affairs leader Nicholas Werner for a wide-ranging conversation on FDA updates, global regulatory uncertainty, robotic surgery controversy, and why nobody seems to know what’s happening with harmonization anymore.

The episode starts exactly where you’d expect: terrible jokes, awkward livestream energy, and an unforgettable discussion about the now-infamous RFK Jr./Kid Rock HHS video. From there, the team dives into several notable FDA approvals and clearances, including Optune Pax for pancreatic cancer treatment, the LimiFlex Dynamic Sagittal Tether as a spinal fusion alternative, and newly approved orthokeratology lenses designed to reshape the eye overnight.

Nick also shares insights from the ophthalmic device world, including the growing conversation around myopia control and how FDA’s approach differs globally.

The conversation then shifts into some of the biggest regulatory debates happening right now:

• Intuitive Surgical’s controversial new 510(k)

• Real-world evidence guidance becoming officially active

• Questions around QMSR expectations for IDE studies

• FDA down-classification discussions

• MHRA’s decision to indefinitely recognize CE-marked devices

• Proposed MDR amendments in Europe

• The potential impact of Melissa Torres leaving FDA on global harmonization efforts

As always, the team balances serious regulatory discussion with plenty of chaos, sarcasm, and stories about daycare illnesses, pirates wearing eye patches, and whether hamster balls could solve pediatric infection control.

Key Topics Covered

• FDA PMA approvals: Optune Pax and LimiFlex

• Orthokeratology lenses and myopia control

• Antimicrobial wound dressing De Novo classification

• Intuitive Surgical’s new robotic surgery 510(k)

• FDA real-world evidence guidance rollout

• QMSR expectations for IDE clinical trials

• FDA device down-classification discussions

• MHRA recognition of CE-marked devices

• MDR amendment proposals in Europe

• Melissa Torres leaving FDA and harmonization concerns

• Moderna vaccine review reversal

• Why CDRH Learn returning matters to industry