“Least burdensome” has become an indelible, almost foundational element to how medical device firms engage with the FDA regulatory process. But it’s not magic. You have to put in the effort, and show your work, to convince the agency why your data plan is just what’s needed to answer the question at hand, explains MCRA’s Tim Marjenin in this edition of Consultants Corner.
Welcome to Consultants Corner, where we check in with independent experts about questions they are answering or challenges they are solving for clients on the front lines of medtech regulatory, reimbursement, and market access.
Tim Marjenin (email@example.com) is VP and Head of Neurology Regulatory Affairs for the global CRO & advisory firm MCRA, where he supports neurological device manufacturers through all stages of the FDA submissions process, from early concept to marketing applications. Before joining MCRA in 2020, he spent 16 years at FDA as a reviewer and review branch chief, primarily for neurostimulation devices.
The Question: Is Least Burdensome Whatever FDA Says It Is?
The concept of “least burdensome” has been baked into FDA’s medical device regulatory framework for more than 25 years now. And it seems simple enough: provide the minimum necessary information to address the right question at the right time in the most efficient manner.
But pinning down what combination of testing and data constitutes least burdensome for a particular premarket submission is not always straightforward. The threshold of “just enough” can vary a lot depending on the details of each project. One thing’s for sure, though, says device regulatory consultant Tim Marjenin: companies should not take for granted that FDA reviewers will have a clear read on where the least-burdensome line should fall. It’s up to firms to make a clear case, the neurology device expert and former FDA review branch chief explains.
Device sponsors tend to assume that “whatever FDA asks us to do, it's going to be least burdensome,” Marjenin says. But engagement between reviewers and the sponsor will often proceed “without anybody ever actually saying, ‘Hey, here are the reasons why we think this actually constitutes a least burdensome approach from all of the other things that we could be doing.’”
In his view, “Companies can usually do a better job of articulating just how the things that they're doing and the approaches that they're taking actually do align with least burdensome principles.”