Common Pitfalls Associated with Modifications to 510(k)-Cleared and 510(k)-Exempt Devices

Posted 21 September 2016 By Pamela Forrest, Jessica Ringel, Lynette Zentgraft

placeholder+image This article identifies some common pitfalls companies often encounter when assessing modifications to 510(k)-cleared and 510(k)-exempt medical devices and offers approaches for performing these assessments to better ensure compliance with FDA expectations.

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

Tags: 510(k), Device Modifications

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