There's nothing like having siblings who are several years older and in their teens. You admire them for being so mature and so big. When you wanted to hang out with them, though, maybe they told you to buzz off. If you work for a firm intent on bringing a PMA device to market, FDA's insistence on a 1,000-patient post-approval study (PAS) for the Sapien transcatheter valve might have given you a bad case of deja vu because a small firm might not be able to get investors on board, even...

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....

There is an Irish aphorism which states: "Anything that keeps a politician humble is healthy for democracy." The same might be said of bureaucrats. What sometimes strikes me as odd is that you can easily find coverage of the miscues of corporate America, but few media outlets are as punctilious about reporting on government's ill-intended moves. Here, then, are five reasons to mistrust government at least as much as device makers. Five: The Thompson Memo In 2003, this memo directed federal prosecutors to offer leniency to a corporate defendant if the defendant was willing to waive attorney-client privilege and/or willing...

First, just to let you know dear reader, this is a Casey Anthony-free blog posting. Those who are skeptical of the device industry in this world are legion, but there are a lot of reasons to cast the occasional baleful glance at government as well. What's interesting is how many in the media automatically assume that any clash between FDA and industry is necessarily the fault of industry. Case in point: I was at the American Diabetes Association annual scientific sessions about two weeks ago and had a conversation with another member of the press. She said more or less...

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...

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...

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,...