Regulatory/Legal
Apr 26, 2007
Much has been written today about a New England Journal of Medicine article that nine in 10 doctors accept gifts from drug and device companies. Of course that...
Apr 20, 2007
If you don't integrate human factors engineering into your design control, you may face eventual consequences from FDA, regardless of your product's...
Apr 18, 2007
FDA announced that it has seized all devices made by Shelhigh, Inc. (Union, NJ) after finding significant manufacturing deficiencies, especially failure to...
Apr 17, 2007
One of the issues AdvaMed and FDA have been discussing as part of FDA's Postmarket Transformation Initiative is the question of when is the best time to file...
Apr 17, 2007
After reinspecting Guidant's cardiac rhythm management site in St. Paul, FDA has lifted a warning letter on the company. Now a division of Boston Scientific...
Apr 16, 2007
FDA and AdvaMed today made public the agreement that should form the basis for the reauthorization of the Medical Device User Fee and Modernization Act (MDUFMA...
Apr 09, 2007
CDRH has debuted a Web site that will keep the public informed about the status of studies mandated by the center as a condition of approval for certain...
Apr 06, 2007
AdvaMed released a statement criticizing CMS' new rule on competitive bidding for certain durable medical goods, orthotics, and supplies. AdvaMed President...
Apr 03, 2007
A column in today's Washington Post ponders whether FDA's increasing reliance on user fees makes the agency too beholden to industry. It discusses this in the...
Mar 30, 2007
Is Abbott the next GE? Or, perhaps we should ask, is the new Abbott the next old Abbott? FDA in a warning letter told the company it is not satisfied with its...