Blog
Ford Recalls Fraction of Vehicles Requested by NHTSA
02-24-2011
Mike Rozembajgier
Ford’s recall of 150,000 of its well-known F-150 model is puzzling, in light of a request by the National Highway Traffic Safety Administration (NHTSA) that Ford recall 1.3 million trucks due to a potential airbag problem. Before it is all over, NHTSA is likely to demand the broader recall, exposing Ford to an additional, and unnecessary, round of negative publicity.
02-24-2011
Mike Rozembajgier
Ford’s recall of 150,000 of its well-known F-150 model is puzzling, in light of a request by the National Highway Traffic Safety Administration (NHTSA) that Ford recall 1.3 million trucks due to a potential airbag problem. Before it is all over, NHTSA is likely to demand the broader recall, exposing Ford to an additional, and unnecessary, round of negative publicity.
Accelerated Medical Device Approval Linked to Product Recalls
02-22-2011
Howard Aughinbaugh
A new study of recalled medical devices highlights the need for thorough safety checks before products are put on the market. This month, a study conducted by the National Research Center for Women & Families and published in the Archives of Internal Medicine found that the majority of the medical devices recalled since 2005 were originally approved using the “accelerated” 510(K) process. Medical device manufacturers embraced the 510(K) for its efficiency, but they probably did not consider its potential impact on recall management.
02-22-2011
Howard Aughinbaugh
A new study of recalled medical devices highlights the need for thorough safety checks before products are put on the market. This month, a study conducted by the National Research Center for Women & Families and published in the Archives of Internal Medicine found that the majority of the medical devices recalled since 2005 were originally approved using the “accelerated” 510(K) process. Medical device manufacturers embraced the 510(K) for its efficiency, but they probably did not consider its potential impact on recall management.
FDA Recall Trends for Food, Drugs, and Devices
02-17-2011
Willie Bryant
There has been a lot of speculation in recent months about Food and Drug Administration (FDA) recall trends. While there appears to be some confusion about the level of the FDA’s recall accountability, one thing is clear. The number of recalls driven by the Center for Drug Evaluation Research (CDER), the Center for Devices and Radiological Health (CDRH) and the Center for Food Safety and Applied Nutrition (CFSAN) is increasing both in terms of the number of recall events and the total number of recalled products
02-17-2011
Willie Bryant
There has been a lot of speculation in recent months about Food and Drug Administration (FDA) recall trends. While there appears to be some confusion about the level of the FDA’s recall accountability, one thing is clear. The number of recalls driven by the Center for Drug Evaluation Research (CDER), the Center for Devices and Radiological Health (CDRH) and the Center for Food Safety and Applied Nutrition (CFSAN) is increasing both in terms of the number of recall events and the total number of recalled products
Food Safety Modernization Act’s Impact Will Go Beyond Food
02-16-2011
Howard Aughinbaugh
The recently enacted Food Safety Modernization Act (FSMA) is designed to improve the safety of the United States food supply in the wake of a string of high-profile food recalls in recent years. An important consideration, however, is how the expanded powers given to the Food and Drug Administration (FDA) by the new legislation will have an impact beyond food processing. This latest example of expanding regulation reinforces the need for careful compliance in a wide range of industries, not just food.
02-16-2011
Howard Aughinbaugh
The recently enacted Food Safety Modernization Act (FSMA) is designed to improve the safety of the United States food supply in the wake of a string of high-profile food recalls in recent years. An important consideration, however, is how the expanded powers given to the Food and Drug Administration (FDA) by the new legislation will have an impact beyond food processing. This latest example of expanding regulation reinforces the need for careful compliance in a wide range of industries, not just food.
Smart Pump Recall Landscape Reiterates the Importance of Recall Preparation
02-14-2011
Mike Rozembajgier
A new report on the reaction from smart pump providers to new FDA standards once again highlights the importance of recall preparedness. Research firm KLAS found that every single smart pump provider has been involved in a recall in the past two years, leading many customers and providers to view recalls as a necessary part of owning smart pumps. While this particular industry may be unique, the lesson remains that recalls are a growing part of everyday life, and companies must be prepared to manage them with comprehensive recall plans.
02-14-2011
Mike Rozembajgier
A new report on the reaction from smart pump providers to new FDA standards once again highlights the importance of recall preparedness. Research firm KLAS found that every single smart pump provider has been involved in a recall in the past two years, leading many customers and providers to view recalls as a necessary part of owning smart pumps. While this particular industry may be unique, the lesson remains that recalls are a growing part of everyday life, and companies must be prepared to manage them with comprehensive recall plans.
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