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Article: More needs to be done to accelerate device reviews--von Eschenbach.(Regulatory Report)
- Article from:
- Medical Design Technology
- Article date:
- April 1, 2006
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Acting FDA Commissioner Andrew von Eschenbach said the agency needs to go beyond the "incremental" improvements it has made in speeding up the review of device premarket applications under the Medical Device User Fee & Modernization Act (MDUFMA).
"In most cases, there has been full compliance with regard to the targets ... that were put into place," von Eschenbach said in testimony to the Senate Appropriations Subcommittee on Agriculture, Rural Development & Related Agencies.
However, meeting the MDUFMA performance goals has not been sufficient to "significantly reduce cycle time and streamline and accelerate the time to market" of devices, he suggested. ...