New Draft Guidance Looks to Update FDA's Replacement Reagent Policy for IVDs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In a new draft guidance released earlier this week, the US Food and Drug Administration (FDA) looks to update a 2003 policy that allows in vitro diagnostic makers to avoid having to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