Devices & Diagnostics Letter

The House Wednesday overwhelmingly approved reauthorizing the Medical Device User Fee Act (MDUFA), sending it on to the Senate with a voice vote.

A new memorandum issued by the U.S. Office of Special Counsel (OSC) instructing federal agencies to ensure their electronic surveillance policies and practices do not deter whistleblowing “confirms” the FDA broke the law when it allegedly monitored the personal emails of employees who voiced product safety concerns to Congress, lawyers for six aggrieved agency staffers say.

Software failures accounted for a quarter of all device recalls in 2011, a new annual report from CDRH’s Office of Science and Engineering Laboratories (OSEL) reveals.

The FDA expects to pilot a mobile version of the MedWatch reporting form on hand-held devices by the end of this year, one of several new software tools the agency is developing to improve postmarket monitoring of adverse events.

The House will use an open amendment process for H.R. 5973, the bill that includes the FDA’s fiscal 2013 appropriations, requiring amendments to be offered on the House floor during the bill’s reading, the House Rules Committee says.

The FDA needs to insist on more quality data in 510(k) premarket notification and premarket approval (PMA) applications and provide real-time postmarket surveillance data that is transparent, Rita Redberg, chief editor of the Archives of Internal Medicine and professor of medicine at the University of California, San Francisco, told the 2012 PharmedOut Conference in Washington, D.C.

The FDA’s Cincinnati District Office issued a Form 483 to a maker of electroencephalogram application caps and related supplies for lack of certain validation and control procedures at its Eaton, Ohio plant.

Last year’s court ruling that sent four former Synthes executives to prison for clinical trial deaths represents an expansion of case law and a warning to other devicemakers, a legal expert says.

A device that helps surgeons detect cancerous tissue during breast cancer treatment could soon reach the U.S. market, if the FDA heeds a June 21 recommendation by its General and Plastic Surgery Devices Panel.

A new government report finds a drop in the length of hospital stays and an increase in patients discharged to the home instead of skilled nursing facilities following implantation of a medical device — and industry says advanced technologies are to thank for that.