The Medical Device Business Journal — Medical Device News & Articles | MassDevice
Federal investigators cleared Food & Drug Administration managers of criminal acts against agency scientists who opposed clearances given to some medical devices, according to the Wall Street Journal.
Anonymous scientists at the federal watchdog agency wrote open letters last year to Congress and President Barack Obama, citing "serious wrongdoing" by top FDA officials and asking Obama to clear house in the Center for Devices and Radiological Health.
Two weeks after hastily yanking its entire field inventory of implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators, Boston Scientific Corp. (NYSE:BSX) officials broke their silence in a series of conference calls with physicians.
BSX CEO Ramond Elliot said the company filed a 30-day notice with the Food & Drug Administration March 15 and 16 and confirmed reports that the FDA will not be expediting its review.
In its effort to improve tracking of medical device performance, the Food & Drug Administration’s Center for Devices and Radiological Health will hold a workshop at the end of April to engage academics in developing analytical tools for things like comparative effectiveness research.
The all day workshop, “Medical Device Epidemiology Network” or MDEpiNet, is slated for April 30 at the FDA’s White Oak campus in Silver Spring, Md.
Food & Drug Administration chief Margaret Hamburg defended the agency’s 23 percent budget increase request for 2011 before a senate panel March 10, saying that the $755 million boost was “crucial to the modernization” of the federal watchdog agency, which regulates nearly 20 percent of all products purchased and consumed in the United States.
In a mostly civil hour of testimony before a Senate appropriations subcommittee, Hamburg reiterated her talking points on the need for increased scrutiny of food, drugs and medical devices. It was her first time testifying before the appropriations committee since being sworn in eight months ago.
By Thomas Lee
Medtronic Inc.’s (NYSE:MDT) Activa deep-brain stimulation device failed to meet the major goals of a clinical study examining its use in treating epilepsy, according to Food & Drug Administration documents.
The Fridley, Minn.-based medical devices monolith’s study of the device, which sends a trickle of electric current to the anterior nucleus region of the brain, failed to demonstrate that patients using the device experienced less seizures than patients in the control group who did not receive the therapy, according to FDA documents.
The Food & Drug Administration warned a Salem, N.H.-based maker of guidewires used in catheters that its quality systems aren’t up to snuff.
Regulators made public March 10 a warning letter sent to Guidewire Technologies Inc., advising the company that they are in violation of three quality systems regulations that must be remedied.
The agency said in a Feb. 26 letter that the company is failing to test each production run to ensure the products have been sterilized and that the company’s Teflon guidewire coating process has not been validated. In addition, the agency said internal quality systems haven’t been audited since 2006.
Healthcare information technology designed to improve patient care might also be the cause of six deaths and hundreds of “adverse events,” a development that’s prompted the Food & Drug Administration to consider regulating the industry, according to a report by the Huffington Post Investigative Fund.
The website obtained advance testimony from newly-minted Center for Devices and Radiological Health chief Jeffrey Shuren, calling for a closer look at whether software programs should face similar regulatory hurdles as medical devices. Shuren is slated to testify before the Health Information Technology Policy Committee Feb. 25.
The Food & Drug Administration is once again making noises about Steris Corp.’s (NYSE:STE) System 1 processor, warning endoscope manufacturers that they must change any labeling indicating that their devices can be reprocessed using the popular sterilizing device.
The Steris System 1 processor is typically used in surgical and endoscope suites for sterilizing and disinfecting medical devices.
In a letter dated Feb. 22, the FDA warned all endoscope makers that they must change the labeling on any devices that state they can be reprocessed using the Steris system and even suggested they add language indicating that “The STERIS System 1 (SS1) is not a legally marketed device.”
The Food & Drug Administration and the National Institutes of Health launched a new program aimed at speeding innovative medical technologies to market.
The joint program involves translational science, “the shaping of basic scientific discoveries into treatments,” and regulatory science, or “the development and use of new tools, standards and approaches to more efficiently develop products and to more effectively evaluate product safety, efficacy and quality,” according to a press release.
For Diana Zuckerman, last week’s open forum on the 510(k) process at the Center for Devices and Radiological Health felt a little like going one-on-400.
The president of the National Research Center for Women & Families told MassDevice she felt quite conspicuous as the lone public health voice in a room full of medical device industry advocates.
“I was pretty much it,” Zuckerman told us. “I think it was all industry, one patient and me and on the discussion panel it was industry plus FDA people and me.”
The Food & Drug Administration convened a day-long public hearing on its 510(k) clearance program for medical devices in Washington, D.C., Feb. 18, drawing comments from a variety of stakeholders.
The program, by which the vast majority of medical devices are approved by the watchdog agency, is often called a "fast-track" program because it relies on previous approvals of similar or "predicate" devices. Supporters of the process say that’s a misnomer; detractors say the system isn’t as rigorous or robust as it should be.
