I've attended more FDA advisory committee hearings than most and believe I have a decent grasp of how those hearings should go. It's true I'm no expert, but recent hearings for medical devices have gone in a direction that strikes me as odd. For instance, at the Jan. 11 meeting of the gastroenterology/urology devices committee, FDA's Herb Lerner, MD, addressed post-market study requirements for an application filed by Torax Medical of St. Paul, Minnesota. Among the items of discussion that day were quality-of-life scores for gastroesophageal reflux and measures of esophageal pH. Lerner said: “This is a very interesting...

Fans of pro football may think the matter of whether Peyton Manning will ever play in the NFL again is taking forever to come to a conclusion, but they might want to examine the FDA whistleblower issue as a benchmark for drawn-out drama. As has been reported in Medical Device Daily, former FDA employees, including Robert C. Smith, MD, and Julian Nicholas, MD, were among the authors of letters to Congress and the Obama administration over alleged suppression of dissent over medical device approvals. Those letters came out in 2008 and...

As mentioned in a posting earlier this week, my wife and I were out for dinner recently and made the acquaintance of some opinions about FDA and the industries it regulates. Opinions about FDA ranged from awful to terrible, and doctors and industry fared no better. It seems a lot of people think user fees conscript FDA, and some see the agency, industry and physicians as some sort of malevolent troika that would have made the Kremlin of Leonid Brezhnev proud. Maybe I'm too close to it...

Forgive me for ripping off Dickens, but a good headline is priceless. This posting, however, is about two tales of an agency (located near Washington) with which we are all familiar. For the first tale, FDA recently re-classified diagnostics for the Yersinia genus of bacteria (Bubonic plague, just in case you were wondering) as covered in the Nov. 18 edition of Medical Device Daily, and FDA stated in the Nov. 17 edition of the Federal Register that an advisory committee had recommended such a change back in 2002. This is not the only example of a request for a device...

Long-time observers of FDA's regulation of therapeutic medical devices will note an oscillation over time, and we are now in a period in which the pendulum has reached as far as it can in one direction and is now headed the other way. The only question is how far. It's not tough to find parties that have a hand in this. Congress finds it difficult to keep a steady hand because there are two parties with their different worldviews. Ditto those in the executive branch. Perhaps there is an inevitability to the back-and-forth at FDA's Center for Devices and...

I don't directly invest in med-tech, but attending Transcatheter Cardiovascular Therapeutics for five years makes me wonder how an investor separates winners and losers. I know TCT 2011 has both, but which are which? Asking about the patient population is just the start of the investor conversation, but in an age in which indications for use are becoming increasingly narrow, it's probably the last question, too. After all, we have radio-frequency ablation devices approved for paroxysmal atrial fibrillation, but not for persistent or long-standing afib....

Anyone who reads this blog on a regular basis knows I'm leery of big government, and I usually criticize government (most often FDA) for what it does rather than what it fails to do. It appears to be time to give FDA the once-over once again, this time over the agency's omissions regarding social media. As readers of Medical Device Daily know, the Center for Devices and Radiological Health has proposed using social media for compliance and enforcement activities, which I covered in the Oct. 7 edition. I should...

  Well, FDA and the Centers for Medicare & Medicaid Services are at it again with parallel review, but this time they've tacitly acknowledged what everyone knew all along; that it would never be willingly adopted by more than a very few device makers. In the Federal Register notice of Oct. 11, the two agencies state that the two-year pilot for parallel review won't accommodate more than five applications per year. When FDA and CMS initially tried to drum up interest in the idea, a number of observers told me industry would never flock to the idea in any numbers...

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...