Jeff Shuren, MD, has brought a lot of changes to FDA’s Center for Devices and Radiological Health, but there are those who think Shuren has not gone far enough while others think he’s gone too far. None of this would matter so much but for the potential for a GOP take-over of the White House. It’s no secret that Shuren’s administration of CDRH has not lacked for controversy, but what some might not realize is the enormous pressure Shuren is under. So what you say? There are several members of Congress who are quite critical of CDRH, but maybe none...

The U.S. Department of Justice sent an Aug. 30 memo to hospitals with a rubric for determining whether an implantable cardioverter defibrillator was justifiably implanted, bringing to a close a nettlesome saga in the annals of cardiology. The memo gives hospitals some leeway in previous use of ICDs outside of Medicare's guidelines, an outcome that was predicted earlier this year by a physician involved in the discussions with DoJ. The news is not expected to take a large bite out of ICD sales according to an Aug. 31 statement by Wells Fargo (WF; New York), however.

Sometimes news comes in bunches. That’s not typically the case in the month of August, which is ordinarily a pretty quiet month. Not this year, though. Here are three stories that stick out, in one case like a sore thumb. Post-market studies for ICD leads FDA announced it will require section 522 studies for a range of ICD leads made by St. Jude Medical. This is not the first time the new FDA has required 522 studies for groups of devices as the 522 orders for surgical meshes, hip implants, and dynamic spinal stabilization systems suggest. I might add that...

St. Jude Medical (St. Paul, Minnesota) had high hopes for its Optim coating process for the Riata ST and Durata lines of leads for implantable cardioverter defibrillators, but according to an article appearing in a European cardiology journal, these leads have failed a conspicuous number of times after four years or less, including the Durata, seen as the lead that would fix all that ails the Riata ST. The news applies yet more pressure on St. Jude, which was recently informed by FDA that it would have to conduct post-market 522 studies on the leads (Medical Device Daily, Aug. 17, 2012), a requirement the firm may yet be able to fulfill with ongoing post-market studies of the devices.