November is not always a spicy month where federal agencies are concerned, but FDA and CMS have come through to give us something to talk about. Below are a couple of items to mull over as you enjoy a leisurely, stress-free drive or comfy, un-cramped flight to celebrate Thanksgiving with loved ones. CMS makes a virtue of necessity The final guidance for the Medicare coverage with evidence development (CED) program is a relatively brief document considering the impact it will have, but also considering the length...
Despite the regulatory approval of new antiepileptic drugs (AED) over the past decade and the expansion of indications deemed suitable for epilepsy surgery, individuals with intractable seizures – roughly one in three epilepsy patients – still face a dearth of treatment options. That void is all the more frustrating because epilepsy remains a debilitating condition for reasons beyond the clinical manifestations, often resulting in chronic unemployment or underemployment, social isolation and poor socioeconomic status. It's no surprise, then, that the prospect of a new treatment for people with medically refractory epilepsy would be greeted with great enthusiasm. As an adjunct...
The Center for Devices and Radiological Health may historically be the most interesting of all FDA’s branches, but the goings-on at CDRH since 2009, the year Jeff Shuren took the helm, have been nothing short of eye-popping. When one looks at the number of lawsuits and withdrawn guidances, it’s difficult to avoid the urge to characterize the past three years in terms of clichés, such as “a bull in a china shop.” Perhaps the poster child for all this was the Menaflex 510(k), which we have discussed before. FDA’s rescission of this application was the most political move at FDA...
By Kelly Roman, Vice President of Fisher Wallace Labs On February 10, 2012, the FDA convened an advisory panel hearing on whether to reclassify cranial electrotherapy stimulation (CES) devices. Despite being a low-risk device, CES has lingered in Class 3 (high risk) for more than 30 years as a result of being a grandfathered 510(k) medical device. The regulatory fate of CES, which is currently cleared to treat depression, anxiety and insomnia, will emerge at a time when antidepressants have been proven ineffective in treating soldiers with post-traumatic stress; CES has had great success treating this population. CES manufacturers such...
The demise of the Global Harmonization Task Force as a regulator-plus-industry forum for harmonization – or “convergence,” as the cautiously optimistic like to say – was met with little more than silence from the trade associations, but one can be sure the off-the-record discussions were intense. Now with the International Medical Device Regulators Forum coming together, the time has come to ask what the future of international medical device regulation holds. First let’s examine the obvious. The chatter about demonstrations of efficacy as a requirement for a CE mark has been going on for some time, and the flap over...
In the March 15 issue of Medical Device Daily, there were two stories that discussed the medical technology industry in the U.S., and neither of them cast a particularly flattering light on the current state of affairs. In fact, it appears that this once proud and successful domestic industry is on life support. Perhaps the most credible criticism came from Tom Fogarty, a legendary entrepreneur in the medical device field. In a story written by Senior Staff Writer Amanda Pedersen, Fogarty asserted that “it’s reached a point in the field of medicine that we in the U.S. are no longer...
The story has been out for a while about transcatheter aortic valve replacement (TAVR), so maybe it's time to project into the future. Before we head there, however, we should revisit the past. The pivotal event in this story is the drug-eluting stent, a device that gave birth to what FDA's Bram Zuckerman, MD, described as the DES trauma. The DES story is twofold; rapid physician adoption and late-stent thrombosis (LST). FDA saw the rate of adoption as an unruly and harmful stampede because of LST, but...
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...
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