Shuren: We're Not In Competition With Europe
This article was originally published in The Gray Sheet
CDRH chief Jeff Shuren says FDA is continuing to reform its regulatory process, especially pointing to the agency's work to shift more data requirements to the postmarket setting, but overall he is confident the US system is close to an "optimal" balance between protecting patients and encouraging innovation.
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During her final public appearance at the National Press Club, outgoing FDA Commissioner Margaret Hamburg defended her tenure and said she was leaving a stronger FDA than the one she inherited. Asked about the agency's device regulatory process, she said she didn't know if FDA or Europe had struck the right balance but said more work needs to be done.
A planning board created to develop a framework for a new U.S. medical device surveillance system has proposed a seven year plan on how to get the system up and running, which will include creating incentive systems for stakeholders as well as reducing the burden of recording and managing device data.