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Shuren: We're Not In Competition With Europe

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.

While industry has often complained devices are able to get to market sooner in Europe than the US because of the CE mark system, Jeff Shuren, director of FDA's device center thinks they have struck the right regulatory balance between public safety and an environment to allow innovation.

Speaking before stakeholders at this year's Transcatheter Cardiovascular Therapeutics conference in San Francisco, Shuren acknowledged medical devices are often available in Europe before the U.S. and the agency is continuing...

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