Medical Devices Today

Medical Device Reports To FDA Rose 77% In 2006

From the August 2007 issue of "The Silver Sheet"

The number of adverse events reported to FDA under the Medical Device Reporting (MDR) program rose last year to an all-time high, and agency staffers predict the trend will continue through 2007.

According to CDRH's Office of Surveillance and Biometrics (OSB), there were 325,742 reports of device-associated injuries, deaths and malfunctions in calendar year 2006 - a 77% increase over 2005, when 184,222 reports were filed.

"Just wait until 2007 is here. At this point we are anticipating a higher number [of MDRs] than last year," said Mary Brady, a deputy division director in OSB. "It all depends on how manufacturers are choosing to report, what they are reporting, and what they consider a reportable event."

Patent Rule Limits Applications, Impacting Device Makers' Filing Strategies

From the August 27, 2007, issue of "The Gray Sheet"

A highly anticipated final rule from the U.S. Patent and Trademark Office puts new limits on the number of applications a company can file for any single invention, potentially requiring changes in device manufacturers' patent strategies.

Published Aug. 21 in the Federal Register, the rule focuses on reducing the number of "continuing applications" that may be filed with PTO.

Continuing applications currently are unlimited and allow applicants over time to add new claims to an original "parent application," thus modifying and broadening the scope of protection for a technology as it develops.

Device Firms Struggle To Find Qualified Quality Assurance Professionals

CDRH Director Ulatowski Recommends Manufacturers Look For Certain Skills

From the July 2007 issue of "The Silver Sheet"

Finding well-trained, highly skilled professionals to fill a variety of quality assurance (QA) positions is proving increasingly difficult for a large number of medical device manufacturers, leading some to encourage people interested in the quality profession to make more use of specialized education and certification programs.

“It just seems like there aren’t enough people to fill the funnel. There’s a big gap,” says Don Middlebrook, VP of regulatory affairs and quality assurance at Pleasanton, Calif.-based Thoratec.

“If you look at the people who have the big [QA] jobs at the moment, they’re all baby boomers, and as they retire and the shifts occur and people are moving around and filling those jobs, it’s creating a vacuum at the lower level,” he says.

Lawmakers Probe FDA Over Handling Of Cordis Warning Letter

From the August 20, 2007, issue of "The Gray Sheet"

The House Energy and Commerce Committee sent letters to FDA and Johnson & Johnson Aug. 13 requesting documents as part of an inquiry into FDA's Office of Regulatory Affairs.

The letters, sent by committee Chairman John Dingell, D-Mich., and Subcommittee on Oversight and Investigations Chairman Bart Stupak, D-Mich., refer to an April 2004 warning letter citing "numerous" manufacturing quality systems violations at six facilities producing Cordis Cypher drug-eluting stents and other vascular devices. The warning letter resulted from FDA inspections conducted in 2003.

"Despite these numerous violations, however, Cordis was allowed to continue marketing Cypher stents," the congressmen write.

Self-Certification For Trial Coverage Will Be Easy, Says CMS

From the August 13, 2007, issue of "The Gray Sheet"

CMS is trying to make it simple for clinical trial sponsors and investigators to get reimbursed by Medicare for routine costs.

"If you can't meet these standards, then you ought to be questioning whether you ought to run the trial," Steve Phurrough, director of CMS' Coverage and Analysis Group, said Aug. 7 during an Open Door Forum on the agency's latest clinical research policy proposal.

The proposal, released July 19, is intended to address confusion that arose after CMS first issued a proposed revision of the original 2000 policy in April (see chart: "Key Proposed Definitions").

"Dear Doctor": FDA Advises Firms How To Alert Physicians Of ICD Risks

From the August 6, 2007, issue of "The Gray Sheet"

Manufacturers should alert doctors about a newly discovered implantable defibrillator risk before their patients learn about it through the media, FDA recommends in a newly released ¹guidance document.

Getting safety information out to doctors as soon as possible "helps them to be better equipped to address patients' concerns and mitigate undue alarm," the guidelines note.