When to Submit a 510(k) (Devices and Software): A Regulatory Perspective

Posted 21 March 2017 By Jeff Ryberg

placeholder+image This article explores key elements of the US Food and Drug Administration's (FDA's) latest draft guidance to industry for deciding when to submit a new 510(k) for medical device hardware and software design changes. The potential business impact is assessed and suggestions are provided for what companies need to do to align with FDA's current thinking.

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

Tags: 510(k), Software

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