Expert Recall

Medical Device Industry Skeptical of Review Process, According to New Survey
06-08-2011
Mike Rozembajgier Here on ExpertINSIGHTS recently we have discussed concerns about the Food and Drug Administration’s 510(k) approval process, including reports that since 2005 fully 70 percent of recalled medical devices had been approved through this fast track process. Not surprisingly, the process has come under fire from safety advocates, academics, and lawmakers alike. In light of this growing criticism, medical device manufacturers should be ready to provide convincing documentation that their devices are safe.

Recalls Lead FDA to Seek Greater Oversight of Foreign Supply Chain
06-02-2011
Howard Aughinbaugh Many attractive business opportunities in today’s global marketplace also present new and complex challenges to consumer safety. As regulators reassess their role in overseeing manufacturers and retailers, they are paying greater attention to industries where the potential for product recalls and recall management is greater than previously expected. Not only are the final products under increased scrutiny, but components and ingredients, regardless of their origin, are quickly becoming targets for regulators looking to crack down on unsafe products.

Following Recalls, CPSC Raises the Standards on Cribs
05-31-2011
Howard Aughinbaugh Beginning June 28, 2011, all cribs sold in the U.S. must meet the new federal requirements set by the U.S. Consumer Product Safety Commission (CPSC). The new regulations were introduced in response to a long list of safety complaints that forced crib manufacturers across the industry to put their recall management to the test over the past decade.

Nissan Takes Recall Notification to the Next Level
05-26-2011
Mike Rozembajgier Too often, we hear about companies waiting too long to alert customers about potential safety problems or facing criticism of their recall management practices from the public or the media. But a recent announcement by Nissan North America shows what responsible companies can do to tackle recall management, and specifically recall notification, in order to keep consumers safe.

Congress and Trade Groups Target Potentially Toxic Chemicals in Consumer Products
05-24-2011
Mike Rozembajgier The American Academy of Pediatrics (AAP) recently issued a report highly critical of what it considers a lack of oversight of toxic chemicals found in everyday consumer products. The report, which focuses on the vulnerability of children and their exposure to potentially dangerous chemicals, calls for “chemical-management policy to be re-written in the United States.”