The question of whether FDA should shoulder the burden of comparative effectiveness research crops up from time to time, but there is more faith in the appropriateness of that notion than I believe is warranted. I only bring this up because Steve Grossman of the Alliance for a Stronger FDA (Washington) raised the issue recently at the Gooznews blog. So let's take a quick look at this issue and examine the question of not just whether FDA is sourced to do this, but whether it should even consider such a task. As for resources, this is a no-brainer. While the...

We who scribble for a living find it easy to go off on those who do not, and today's bulls-eye is on the patent reform bill recently signed into law, the America Invents Act of 2011. One of the interesting things about H.R. 1249 is that it puts some of the fees collected by the U.S. Patent and Trademark Office in an escrow for Congress to decide whether to release to PTO. I've asked a number of people around Washington whether they think Congress can resist the temptation to write PTO an IOU and just keep the money, and almost...

FDA has published the much-anticipated guidance for the de novo device application channel, and as promised has opened a new regulatory door that allows a device maker to avoid the need for obtaining a determination of not substantially equivalent (NSE) for moderate- and low-risk devices. The guidance calls for a sponsor to file a pre-de novo (PDS) submission as an alternative to wrangling with the 510(k) channel first, but a firm that obtains the agency's nod to go ahead with the de novo filing can file a parallel application for the device as a 510(k) and as a de novo. (Medical Device Daily)

As a member of the trade press, I get a kick out of how routinely some people in the mainstream media and the population at large routinely assume that device makers are driven by greed and that doctors are morally flawless creatures who spend all their spare time pondering the public weal and woe, continuously devising ways to ensure their passage through the Pearly Gates with constant acts of selflessness. And then I see the parties weighing in on the question of Medicare coverage for the Sapien aortic valve made by...

When someone describes FDA and the Centers for Medicare & Medicaid Services as sister agencies, they may be on to something if the CMS report regarding a coverage analysis for the Sapien aortic valve made by Edwards Lifesciences (Irvine, California) is any indication. The Sept. 28 CMS memo indicates that the agency heard loud and clear the message FDA intended to send during the advisory committee hearing earlier this year, which conveyed the notion that FDA is not keen on seeing this device migrate into anything but a heavily staffed facility with personnel who are well versed in this type of procedure (Medical Device Daily, July 22, 2011). (Medical Device Daily)

WASHINGTON – Jeff Shuren, MD, made the obligatory stop at AdvaMed 2011, the annual conference sponsored by the Advanced Medical Technology Association (AdvaMed; Washington), at a time when industry is reacting sharply to several guidances, including the when-to-file guidance for 510(k) submissions. (Medical Device Daily)