Category Archives: CDRH

Thank you government!

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,…

FacebookTwitterGoogle+Share

Statistical tinkering in device regulation a disservice to patients

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…

FacebookTwitterGoogle+Share

Bull in a China shop: Jeff Shuren at CDRH

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…

FacebookTwitterGoogle+Share

FDA misconduct not deemed newsworthy

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…

FacebookTwitterGoogle+Share

The future of device regulations: the EU model or the FDA approach?

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…

FacebookTwitterGoogle+Share

Is the U.S. no longer the dominant player in med-tech?

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…

FacebookTwitterGoogle+Share

TAVR: What it says about FDA and CMS

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…

FacebookTwitterGoogle+Share

FDA advisory committees: Is there a problem?

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…

FacebookTwitterGoogle+Share

FDA whistleblowers sue FDA: A big deal?

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…

FacebookTwitterGoogle+Share

Risks and patients: Should FDA and industry close the perception gap?

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…

FacebookTwitterGoogle+Share

Marketo