FDA's Center for Devices and Radiological Health published the results of its analysis of decisions on 510(k) applications between 2006 and 2010 (see the pdf of the report here), including some data from as far back as 2001, and several features jump out to the casual observer. The problem for CDRH managers is that the report suggest a number of stories – several of which the agency fails to tell – that will do nothing to dial down industry's pushback against FDA's more aggressive enforcement/compliance regime. The report is also certain to do nothing to drain the increased pressure on...
Last week, the Advanced Medical Technology Association (AdvaMed; Washington) put on its Superman cape and unveiled a set of policy recommendations that it hopes will preserve America's position as a leader in medical technology innovation. Dubbed the Competitiveness Agenda (which can be seen in more detail by clicking here), AdvaMed is issuing out a call to arms to the government to not overlook the med-tech industry. Here's the problem that the med-tech industry is facing. Imagine for one moment that you're on the brink of not being able to pay your mortgage. Slowly and steadily you're getting behind on the bills...
ReGen Biologics (Hackensack, New Jersey) has filed suit against FDA over the agency's rescission of the firm's Menaflex application, a slugfest that is certain to draw intense interest everywhere, from Capitol Hill to the boondocks of the medical device industry. This might be a lawsuit that wends its way quietly into history, but it could also rupture whatever cohesiveness there might be at the agency's Center for Devices and Radiological Health. At the very least, it will serve as a huge distraction for CDRH officials and impose yet more drag on operations...
Earlier this month my wife and I had a beautiful baby daughter, and as you can imagine, the demands for pictures are flooding in. This can be pretty problematic for us seeing as how we don’t really have a Facebook page, where we can disseminate pictures to all those who are requesting a glimpse of our lovely daughter's visage, in one click of a button. Everything with us, is done by email or text messages. But there’s a reason for that, and a good one. See we don’t really want our message out for the whole world to see. My wife and...
Is the sky falling? Device makers keep saying so By MARK McCARTY Medical Device Daily Washington Editor FDA's Center for Devices and Radiological Health is certainly on a regulatory tear of late, and industry is understandably rattled by some of the developments. After all, CDRH only recently managed to shed a couple of obvious malcontents in the persons of Robert Smith, MD, and Julian Nichols, MD, who both worked at the Office of Device Evaluation at CDRH and were not exactly happy to get their walking papers. My impression is that you have to be either really obnoxious, noticeably incompetent,...
Top 10 reasons interventional cardiologists should be happy By MARK McCARTY Medical Device Daily Washington Editor Dear Interventional Cardiologist, Worried about Medicare reimbursement for the Next Great Stent? Concerned that FDA's massive regulatory girth will squash your drug-eluting balloon groove? Not to worry. Here are the top 10 reasons you should be thrilled with your choice of specialty. Number 10: PCI numbers are flat of late, but just watch that Baby Boom fill your waiting room in the years to come. Number 9: The transradial (through the wrist) route is gaining acceptance as an approach to coronary intervention. Number 8:...
It’s easy to understand the excitement about the PARTNER trial, sponsored by Edwards Lifesciences (Irvine, California), the company that makes the much talked about transcatheter aortic valve replacement (TAVR) device, called the Sapien. After all, given the choice between open heart surgery or a non-surgical alternative most patients would prefer the latter. However, the data from the study, which was presented earlier this week at the American College of Cardiology (Washington) annual meeting in New Orleans, showed that TAVR patients were also more likely to have a stroke following the procedure. In the study, major strokes were higher for TAVR...
In January when the FDA unveiled its 25-point plan to change the 510(k) clearance program, currently the quickest and most commonly used pathway to getting a medical device to market in the U.S., it appeared that a smooth landing might be in the works for the med-tech industry. That landing, however, was deferred, saddling the program with one of the greatest annoyances to any airline passenger, the dreaded holding pattern, when it was revealed that 30 other more controversial recommendations from the FDA working groups were being delayed. Among the most contentious recommendations being postponed was one for CDRH...
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