New FDA guidance for dual submission 510(k) and CLIA waiver application for IVD companies

By Stewart Eisenhart, Emergo Group

New guidance from the US Food and Drug Administration explains requirements for in vitro diagnostic manufacturers to register for premarket notification using the agency’s Dual 510(k) and Clinical Laboratory Improvement Amendments (CLIA) Waiver by Application.

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

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