FDA, medical device industry form research partnership
Dec 3 (Reuters) - 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 products.
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 teleconference.
Medical device makers involved in the consortium include Medtronic Inc, Boston Scientific Corp, Becton Dickinson and Co, Abiomed Inc and Cyberonics Inc.
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