Blog
FDA’s Medical Device Software Oversight Faces Increasing Scrutiny
09-14-2011
Mike Rozembajgier
The Food and Drug Administration’s (FDA) 510(k) review process continues to face scrutiny due to its failure in regulatory oversight of medical device software, which has caused hundreds of deaths in the past several years according to a recent Los Angeles Times article. Under the FDA’s 510(k) process, approximately 70 percent of medical devices that have been recalled since 2005 were originally approved for sale. This number illustrates a primary source of concern for both manufacturers and patients.
09-14-2011
Mike Rozembajgier
The Food and Drug Administration’s (FDA) 510(k) review process continues to face scrutiny due to its failure in regulatory oversight of medical device software, which has caused hundreds of deaths in the past several years according to a recent Los Angeles Times article. Under the FDA’s 510(k) process, approximately 70 percent of medical devices that have been recalled since 2005 were originally approved for sale. This number illustrates a primary source of concern for both manufacturers and patients.
FDA Announces New Inspection Fees
09-12-2011
Mike Rozembajgier
In an effort to fully implement the Food Safety Modernization Act (FSMA), the Food and Drug Administration (FDA) has announced that it will charge food manufacturers and importers higher fees to cover inspection and holding costs. These fees—set to take effect on October 1—will be a considerable burden for food manufacturers and should encourage better compliance and help prevent future recalls.
09-12-2011
Mike Rozembajgier
In an effort to fully implement the Food Safety Modernization Act (FSMA), the Food and Drug Administration (FDA) has announced that it will charge food manufacturers and importers higher fees to cover inspection and holding costs. These fees—set to take effect on October 1—will be a considerable burden for food manufacturers and should encourage better compliance and help prevent future recalls.
Top Brands Continue to Use Triclosan while the FDA Studies Potential Dangers
09-08-2011
Mike Rozembajgier
The Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA) are studying the safety of triclosan, a common chemical found in in over-the-counter antibacterial soaps, deodorants, toothpastes and cleaning products. If regulators end up declaring triclosan to be unsafe, the marketplace impact could be substantial, and it could lead to major product recalls.
09-08-2011
Mike Rozembajgier
The Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA) are studying the safety of triclosan, a common chemical found in in over-the-counter antibacterial soaps, deodorants, toothpastes and cleaning products. If regulators end up declaring triclosan to be unsafe, the marketplace impact could be substantial, and it could lead to major product recalls.
Ill-Timed Recall Alerts Require Follow Up Messaging
09-07-2011
Mike Rozembajgier
When the United States Department of Agriculture’s Food Safety and Inspection Service (FSIS) decided to recall 8,500 pounds of E. coli tainted ground beef processed by Cargill Meat Solutions, the agency issued the order just after midnight on Friday, August 28, 2010. This prompted food safety expert Bill Marler to wonder if FSIS was deliberately issuing recall notices when consumers are least likely to pay attention. Further investigation revealed that, in fact, recall notices have been released at all hours of the day and all days of the week.
09-07-2011
Mike Rozembajgier
When the United States Department of Agriculture’s Food Safety and Inspection Service (FSIS) decided to recall 8,500 pounds of E. coli tainted ground beef processed by Cargill Meat Solutions, the agency issued the order just after midnight on Friday, August 28, 2010. This prompted food safety expert Bill Marler to wonder if FSIS was deliberately issuing recall notices when consumers are least likely to pay attention. Further investigation revealed that, in fact, recall notices have been released at all hours of the day and all days of the week.
Revolutionary Produce Tracking Network on Track for Completion in 2012
09-01-2011
Mike Rozembajgier
The Produce Traceability Initiative (PTI) will revolutionize the way produce growers, packers, processors and sellers track their products from farm field to table. As previously discussed by ExpertINSIGHTS, this system has the ability to pinpoint tainted batches of produce and thereby make recall management easier, cheaper, and more effective — in turn leading to a safer food supply and a lot less confusion in the event of a recall.
09-01-2011
Mike Rozembajgier
The Produce Traceability Initiative (PTI) will revolutionize the way produce growers, packers, processors and sellers track their products from farm field to table. As previously discussed by ExpertINSIGHTS, this system has the ability to pinpoint tainted batches of produce and thereby make recall management easier, cheaper, and more effective — in turn leading to a safer food supply and a lot less confusion in the event of a recall.
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