ARTICLE SUMMARY:
The sharp drop in 2019 novel device approvals is no cause for panic—all the fundamentals look good, FDA device director Jeff Shuren says, in this week's top medtech policy news pick from MedTech Strategist Market Pathways.
[For a complete roundup of global medtech policy happenings that should be on your radar this week and deeper analysis of the sector, check out Market Pathways.]
The number of novel medical devices approved by FDA came back down to earth in 2019. But that shouldn’t be a cause for concern, stresses Jeff Shuren, the agency’s medical devices chief. Shuren recently spoke with me for an article in Market Pathways looking at recent device review and approval trends at FDA.
Close FDA watchers have noticed the significant rise in approvals of PMA devices and also of devices going through the de novo route starting in 2015. The numbers kept on increasing to new record levels for each of the next three years. FDA’s ballooning approval numbers almost became an annual expectation, even as resources and reality dictated they would have to drop at some point. That point was reached in 2019, when the trendline took a sharp turn downward—about a 30% reduction in novel device approvals, according to Market Pathways’ calculations.
The latest numbers could be viewed as a cause for concern in what has largely been a period over the last decade of increased efficiency and transparency at FDA’s device center. But Shuren said such a takeaway would be a mistake. “When we look at the total picture, we don't see that there's some underlying problem and we expect those numbers to fluctuate,” he told me. The bottom line, he says, is that the US device pipeline in FDA’s view is as strong as its ever been, and that fact does not necessarily get captured in a single year’s worth approval data.
In the Pathways article, I also talk to Shuren about trends data in FDA review decisions times, which are trending downward as manufacturers spend less time responding to agency questions; the Breakthrough Device Program, which is growing like gangbusters; and device review program policy priorities for 2020. Read the article here.
For some bonus FDA content from Market Pathways, check out Steve Levin’s recent article on the successes and challenges of the US Early Feasibility Study program. And, while you’re at it, look up my mid-2019 interview with Shuren about his growing frustrations with FDA’s lack of flexibility to respond to new technology with new regulatory paradigms.
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