Category: Regulatory
Food & Drug Administration chief Margaret Hamburg calls the agency's $775 million budget-boost request "crucial to the modernization" of the agency, but Senate panel members express concerns in 2011 budget session.
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.
A clinical trial conducted by Medtronic of its Activa deep-brain stimulation device and epilepsy failed to meet its own goals, according to the Food & Drug Administration, which also raises safety concerns about the DBS device.
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.
Salem, N.H.-based Guidewire Technologies earns a warning letter from the Food & Drug Administration for quality system violations at a manufacturing plant.
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.
Cardiac device will know be able to sell its Trifecta aortic valve replacement in the European union.
By Brandon Glenn
LITTLE CANADA, Minnesota — St. Jude Medical Inc. (NYSE:STJ) won European approval to begin selling its Trifecta valve, which is designed to replace a patient’s damaged aortic valve.
The Institute of Medicine, charged with examining the process by which a majority of medical devices are cleared for market, holds its first public meeting on the 510(k) process March 1.
The Institute of Medicine will kick off the first of two public meetings on the 510(k) pre-market clearance system for medical devices this afternoon, as part of its investigation into the public health effectiveness of the program.
The IOM, which the Food & Drug Administration tapped for a $1.3 million study of the 510(k) program in September 2009, will conduct the meeting from 1:00 to 5:30 p.m. at the Keck Center of the National Academies in Washington, DC.
The meeting agenda includes a presentation on the history of the 510(k) program and an overview of how it operates, which will be given by representatives from the FDA. A public comment session is scheduled to follow.
The Food & Drug Administration considers expanding its brief to cover the health information technology sector, prompted by reports of six deaths linked to electronic medical records gone awry.
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 tells manufacturers they must revise any labeling indicating that their devices can be reprocessed using the Steris System 1 sterilization system.
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."
