Ms. Sebelius noted that user fees for pharmaceutical companies have cut drug review times in half and the same could be done for devices. She asked devicemakers to work with the FDA to develop a plan that “holds us accountable.”
The industry and the FDA are in negotiations over reauthorization of a new set of medical device user fees to replace the current ones, which expire in 2012.
Related Articles on the Medical Device Fees:
Devicemakers Warn FDA Against Becoming Dependent on User Fees
Devicemakers Ask Congress to Ease Regulatory Burdens on Industry
Medical Device Lobby Calls for 6 Changes in Federal Policy
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