Regulatory/Legal
Jun 06, 2007
FDA this week announced the formation of a 15-member committee to advise it on how to improve communication regarding risks and benefits of medical devices and...
Jun 05, 2007
Dr. Steven Nissen, head of the Cleveland Clinic's department of cardiovascular medicine, has made a name for himself as an FDA watchdog in recent years. He was...
May 31, 2007
A federal judge refused to grant Shelhigh Inc.'s request that the government release the tissue-based devices it seized last month because of concerns about...
May 30, 2007
James Mazzo, president and CEO of Advanced Medical Optics, told the media that the recall of its contact lens solution is not related to a manufacturing...
May 29, 2007
FDA announced late last week that Advanced Medical Optics (Santa Ana, CA) has voluntarily recalled its Complete MoisturePlus Multi Purpose Solution for soft...
May 23, 2007
Legal action that takes place in the drug industry is an indication of areas where device companies need to be cautious. Although the device industry is quite...
May 21, 2007
The relationship between hospitals and the medical device industry needs more integration, proclaimed Mary Ann Hilliard, chief risk counsel for the Children's...
May 17, 2007
So maybe it’s not so strange to think of a patient as a washing machine. That is, it’s not a bad idea to give a patient the same kind of warranty that a...
May 16, 2007
Shelhigh Inc., which had its inventory of tissue-based implants seized by the government because of concerns over sterility, has gone to court to get them back...
May 14, 2007
CDRH has unveiled two pathways to facilitate electronic Medical Device Reporting. This will hopefully increase the volume of MDRs, which are underreported....