Dec 3 The U.S. Food and Drug Administration said
it has formed a partnership with the medical device industry
aimed at speeding the development and review of new device
The nonprofit organization, called the Medical Device
Innovation Consortium, will collaborate with patient support
groups, academia, foundations and the Centers for Medicare and
Medicaid Services to improve the process for bringing medical
devices into the marketplace.
The move comes as device makers push the FDA to speed up the
review of devices, while advocacy groups contend the agency is
doing too little to protect consumers.
The partnership will boost investment in regulatory science
research by pooling people, funding and ideas to develop new
methods to better evaluate devices, FDA said.
"It really is going to represent a model that will be
watched carefully, will be replicated. I know there will be real
advances and new approaches that will emerge from it," FDA
Commissioner Margaret Hamburg told reporters on a
Medical device makers involved in the consortium include
Medtronic Inc, Boston Scientific Corp, Becton
Dickinson and Co, Abiomed Inc and Cyberonics