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New Draft Guidance Looks to Update FDA's Replacement Reagent Policy for IVDs By Michael Mezher - Published 22 December 2017

In a new draft guidance released earlier this week, the US Food and Drug Administration (FDA) looks to update a 2003 policy that allows in vitro diagnostic makers to avoid having to submit a new 510(k) for certain changes to their tests.

Categories: News, US, FDA, In vitro diagnostics, Submission and registration

Tags: Replacement Reagent, Instrument Family, In VItro Diagnostics