FDA’s 2027 Priorities, Human Factors & Breakthroughs
This week on Trying to Keep Up, Allison Komiyama and Michael Nilo are joined by Tim Marjenin, Vice President of Neurology Regulatory Affairs at MCRA. Tim spent 16 years at the FDA as a lead reviewer and manager in the neuro group, giving the team plenty to discuss about what happens on both sides of the review process.
The conversation starts with a long-awaited update: the FDA finally published the De Novo decision summary for SmartFlow Neuro Cannula after more than two years. The device supports delivery of therapeutics directly into brain tissue, prompting a discussion about neurology, gene therapy delivery systems, and why De Novo decision summaries can take so long to become public.
From there, the team digs into one of the increasingly visible issues in medical device submissions: human factors. They discuss the growing scrutiny of usability, the challenges of responding to highly prescriptive deficiencies, and why home-use devices can create especially complex human factors questions.
Tim also weighs in on the evolving value of Breakthrough Device Designation. The group discusses whether Breakthrough still delivers meaningful regulatory advantages, how selective review teams have become, and where faster interactions can still make a difference.
Additional topics include:
The new Liverty™ TIPS Stent Graft PMA and the long road behind PMA products
Q-Sub strategy and why asking the right questions matters
Collaborative FDA review and the value of direct communication with review teams
The FDA’s FY2027 proposed guidance priorities
Upcoming guidance for AI-enabled device software and generative AI-enabled conversational devices for mental disorders
Robotically assisted surgical devices and increasing levels of autonomy
PCCPs, cybersecurity, ASCA, and possible Q-Sub updates
Why human factors and cybersecurity remain areas every device team should prepare to defend
The FDA’s FY2027 list offers a useful preview of the issues likely to keep regulatory teams busy, and if this episode is any indication, there will be plenty to keep up with.
Links & Resources
New Breakthrough Device Designations
Draft Guidance: Robotically Assisted Surgical Devices – Premarket Submissions
Dec. 2-3 Public Workshop: Evaluating Benefit-Risk in Robotic Medical Devices with Autonomous or Remote Teleoperation Capabilities
Grindr to Acquire Freddie HIV Prevention Telehealth Provider
FDA Databases
