Minnesota’s medical device companies have openly fretted about the Food and Drug Administration altering or even eliminating the popular 510(k) clearance program.
From venture capitalists and entrepreneurs to doctors and academics, the industry has complained that the FDA is already taking too long to make decisions, a harbinger of worse things to come. And since Minnesota is home to prominent cardiovascular companies like Medtronic Inc. (NYSE: MDT) and St. Jude Medical Inc. (NYSE: STJ), this region has a lot more to lose.
But a closer look at FDA 510(k) data complied by Mass Device (MedCity News’ content partner) suggests a more complicated picture. The agency actually approved more cardiology devices last year than 2008, a 13 percent jump to be exact. And it took the FDA less time to do it, 104 days versus 107 days.
If there are industries that have good reason to sweat, it’s orthopedics and surgical instruments. 510(k )approvals for orthopedic devices fell nearly 14 percent last year and 10 percent for surgical devices. It took the FDA 21 more days to clear an orthopedic device (120 days vs. 99 days) and six more days to green light a surgical device (118 days vs. 112 days).
So what gives? The most obvious answer: the FDA has naturally increased its scrutiny of orthopedic devices in light of the now infamous ReGen Biologics Inc. fiasco. The agency reversed its approval of ReGen’s knee cartilage implant after it concluded outside parties improperly pressured regulators.
The real question now is whether the FDA will apply that same extra layer of caution toward all devices that seek 510(k) approval. The agency is expected to unveil a series of changes to the program later this year. FDA device chief Dr. Jeffrey Shuren said the changes were long coming and have nothing to do with ReGen.
“A lot of people have asked did we do this over ReGen. The answer is no,” Shuren said recently. “These issues we uncovered in 510(k) were circling around for a while.”
The data suggest otherwise. This, of course, doesn’t mean Minnesota can breathe easy now. Cardiovascular devices may get all the glory in these parts of the woods. But the state is also home to a thriving orthopedics industry.
Minnesota received 124 510(k) clearances in 2009, down 10 percent from the previous year. I’m willing to bet that has something do with orthopedics.
Just ask Disc Dynamics.