Regulatory/Legal
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...
Mar 30, 2007
"The medical device industry is no longer under the radar screen," assessed AdvaMed's president and CEO, Stephen Ubl during a conference at Harvard University...
Mar 29, 2007
How confusing is Japan's premarket approval system? CDRH official Larry Kessler, chair of the Global Harmonization Task Force, used that word to describe it at...
Mar 23, 2007
In the fall, FDA and Health Canada launched a pilot program allowing authorized third-party inspectors to cover US and Canadian requirements in a single...
Mar 22, 2007
Experts who advise FDA on the approval of a medical device or drug could soon be facing much tougher rules. In efforts to further limit conflicts of interest,...