Regulatory/Legal
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....
May 10, 2007
The Senate yesterday passed the FDA Revitalization Act, which includes the new version of MDUFMA, 93-1. The bill is getting more coverage in the media for its...
May 09, 2007
The federal antikickback investigation against five orthopedics manufacturers could end as soon as this summer, reports the Star-Ledger of Newark, NJ....
May 08, 2007
The Senate yesterday shelved a controversial amendment that could have impeded the enaction of the bill that includes the new version of MDUFMA, the Los...
May 04, 2007
President Bush has announced his intention to nominate Kerry Weems as the new administrator of CMS. Weems is currently the deputy chief of staff at the...
May 03, 2007
FDA has taken the rare step of formally asking a device company for a recall. The agency wants Shelhigh Inc. (Union, NJ), whose headquarters it raided two...
May 02, 2007
Medical device companies are fine with paying higher user fees as long as it leads to a more predictable, streamlined process, reports the Record of Hackensack...
Apr 30, 2007
Today is the public meeting on the new version of the Medical Device User Fee and Modernization Act, which must be passed by Congress by the end of September....
Apr 27, 2007
Becton Dickinson (Franklin Lakes, NJ) wants to get a test on the market that can tell the difference between regular staph infections and drug resistant forms...
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...