Much has been made of the slow-down in device approvals at FDA's Center for Devices and Radiological Health, and the explanations range from a preoccupation with scientific and statistical minutia to a paranoia that yet another incident will subject the agency to another lashing in the court of public opinion. But let's face it, FDA gets some pretty shabby treatment on Capitol Hill, too. I recall a hearing in which then-Senator Hillary Clinton (D-New York) grilled incoming FDA commissioner Andrew von Eschenbach, MD, like a common criminal. She and Sen. Patty Murray (D-Washington) never allowed von Eschenbach to completely answer...

  The title of this posting pretty much says it all, but I'm paid to tap out words on my keyboard. So here we go. Remember FDA's draft guidance on when to file a 510(k)? Among the things it stipulates is that if a manufacturer makes a change that requires a new 510(k) filing, the manufacturer cannot cite any predicates other than those that were already cited in that device's filing. So what's a device maker to do? Cite every potential predicate it can. Why? You have to ask? Yes, yes, FDA wants to cut down on the use of...

  As the saying goes, there are things we know we don't know, but here are three things we do know, namely guidances that will affect device makers. One of these might have the effect of making some clinical trials less expensive, but another could put the brakes on provider training even in first-in-human studies unless the sponsor is willing to roll out a training protocol for all physician users in the post-market setting. FDA to put brakes on surgeon training? FDA issued a mid-August draft guidance for device clinical trials indicating antipathy toward a sponsor's training of doctors in...

In the world of diagnostic and therapeutic devices, 2011 has already been a busy year, but a third of the year remains. There are still numerous developments that will trigger cheer and jeers, depending on where you sit. This is not an exhaustive list of things that could arise in the last half of this year, but these are all pretty big, and a lot of people will be watching carefully. FDA meeting on IOM 510(k) report: FDA recently invited all interested parties to talk about the recommendations made recently by the Institute of Medicine regarding the 510(k) device clearance...

Those in the business of therapeutic or diagnostic devices know how quickly things can change, so let's take a quick look at a few stories that appeared in Medical Device Daily in August 2009. After all, two years are less than the average time needed to get a patent through the U.S. Patent and Trademark Office, which is another story. Aug. 12, 2009: Schultz out at CDRH; Shuren to serve as interim director On Aug. 11, 2009, the Internet was abuzz with reports that Dan Schultz, MD, had stepped...

Tuesday night during its quarterly meeting, the Southeastern Medical Device Association (SEMDA; Norcross, Georgia) unveiled its new logo and its new website, which is set to go live in the very near future. SEMDA seems to be increasing its presence and that’s a good thing because it and other trade associations are going to play a very important role in helping med-tech companies traverse the healthcare landscape in the near future. And med-tech companies are going to need it. The upcoming changes set to take place on the healthcare landscape are going to have a dramatic impact on med-tech companies...

The deal struck by Medtronic (Fridley, Minnesota) regarding an evaluation of adverse events associated with off-label use of the InFuse bone morphogenic protein is conspicuous, but not so much because it will cost the firm $2.5 million to have Yale University (New Haven, Connecticut) review the data, as reported in the Aug. 5 edition of Medical Device Daily. As described by MDD managing editor Holland Johnson, this effort will be made very public and is being touted as a new level of transparency that may set the standard for future such activities. In the meantime, however, it might be enough...

If you enjoy participating vicariously in exercises in futility, take a gander at what's going on in Washington with regard to user fees for medical device reviews. Yesterday, Sen. Richard Burr (R-North Carolina) told FDA commish Margaret Hamburg, MD, than any user fee legislation that does not incorporate non-FDA days into the calculation of total 510(k) review days would face “a long and laborious process” to get the required legislation through the Senate Health, Education, Labor and Pensions Committee. Burr's position was essentially that FDA has not met the turn-around on applications called for in the previous user fee handshake,...

In this blog, we've explored the issue of NIH funding twice. The first time, we examined the reported fiscal spending numbers (here) and the second time, we examined funding by program areas (here), but now we have the budget/deficit ceiling debate, and yet we still see examples of truly nonsensical arguments about NIH funding. Let's acknowledge at least one thing: It makes no sense to fatten the NIH basic research pipeline when we know FDA can never keep up with it. It's akin to putting up a larger water...

I remember reruns of a cartoon about a character named Tooter Turtle, who was always appealing to Mr. Wizard to send him back in time for some form of jollies or other, and when the whole thing went south, Tooter would yell out, “help Mr. Wizarrrrrd!” At which point, Mr. Wizard would cluck about the futility of it all in his central European accent and bring Tooter back with the incantation, "drizzle, drazzle, druzzle, drome; time for zis one to come home." I never had any idea what that drizzle-drazzle stuff was all about, but it worked for Mr. Wizard....