QUOTED. Dec 19, 2017. Jeff Shuren.
Executive Summary
Check out what US FDA device-center director Jeff Shuren had to say about an alternative 510(k) pathway the center is developing that does not depend on a technology comparison to a predicate device.
"You can really say, this isn't your grandmother's device and it isn't your grandmother's standard." – Jeff Shuren, director, US FDA Center for Devices and Radiological Health
> Find out more: A No-Predicate 510(k) Future? Pending US FDA Policy Might Forge A Path
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