Regulatory/Legal
Jun 23, 2006
An FDA analysis conducted last year concluded that Guidant implantable cardioverter-defibrillators were 10 times more likely to fail than the company had let...
Jun 22, 2006
FDA's San Francisco District and AdvaMed have announced a public workshop on device regulations, geared toward assisting small and start-up manufacturers. It...
Jun 20, 2006
CDRH has been busy getting inspection-related guidance documents ready. Last week it published the latest version of its general guidance document on...
Jun 19, 2006
Acting FDA Commissioner Andrew von Eschenbach says all the right things. At last week's annual meeting of the Medical Device Manufacturers Association, he made...
Jun 13, 2006
Medtronic has received reimbursement approval in France for its Endeavor drug-eluting coronary stent system. The stent is now available in all Western European...
Jun 12, 2006
Judges are continuing to obtain more power over intellectual-property decisions affecting devices and other industries, MD...
Jun 02, 2006
Citing the lack of uniformity in the size of medical devices and their packaging, FDA a few years ago decided not to require devices to be bar-coded or...
May 25, 2006
Earlier this week, CDRH announced it will pursue an optional MDUFMA goal regarding 510(k)s but not one regarding PMAs. For fiscal year 2007, it aims to render...
May 23, 2006
CDRH has announced the launch of the Medical Device Innovation Initiative, which is the center's contribution to FDA's Critical Path Initiative to get new...
May 22, 2006
Finally, a mainstream media article dismisses the concept of "zero risk" for medical devices. In his Boston Globe piece on last week's Heart Rhythm Society...