Fundamentals and Global Impact of 510(k) for Medical Devices

Posted 11 February 2016 By Mingzi Deng, RAC, Shrenik Desai, MS, RAC, Aastha Kohli, MS, RAC, Lewis Lau, RAC, Mukesh Kumar, RAC, Marko Spaic, Dejan Ratkov, BScEE

placeholder+image This article presents an overview of the fundamentals of 510(k) submissions, including the impact of the unique regulations to US and foreign device manufacturers.

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Categories: Medical Devices, Submission and registration, Features, US, CDRH

Tags: 510(k), Preamendment devices, Third party review, Abbreviated 510(k), Special 510(k)

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