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510(k)

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FDA publishes new 510(K) guidance

Photo of Yvonne Puig (US)Photo of Mark Faccenda (US)Photo of Jeff Wurzburg (US)
By Yvonne Puig (US), Mark Faccenda (US) & Jeff Wurzburg (US) on January 24, 2019

On January 22, 2019, the FDA released nonbinding guidance expanding the Abbreviated 510(k) program used to show the safety and efficacy of medical devices.  A new “safety and performance-based pathway” for certain, well understood device types, may be used by…

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