FDA issues final guidance on medical device changes that need new 510(k) submissions

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Emergo GroupBy Stewart Eisenhart, Emergo Group

Medical device regulators at the US Food and Drug Administration have published final guidance explaining when changes to registered devices warrant filing new 510(k) premarket notifications to the agency.

Get the full story here at the Emergo Group’s blog.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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