By Stewart Eisenhart, Emergo Group
The US Food and Drug Administration’s medical device oversight division has rolled out final guidance on an expanded 510(k) registration route retooled to focus on device safety and performance issues, and is seeking industry comment on proposed changes to its predicate device policy.
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.
The post FDA final guidance on safety and performance 510(k) medical device registration appeared first on MassDevice.
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