New Draft Guidance Looks to Update FDA's Replacement Reagent Policy for IVDs

Posted 22 December 2017 | By Michael Mezher 

New Draft Guidance Looks to Update FDA's Replacement Reagent Policy for IVDs

In a new draft guidance released earlier this week, the US Food and Drug Administration (FDA) looks to update a 2003 policy that allows in vitro diagnostic makers to avoid having to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

Under the policy laid out in the 2003 guidance, IVD makers can add either a cleared reagent to a previously cleared instrument or a new instrument "family member" to a previously instrument family without requiring a new 510(k).

FDA says the policy is meant to ease burdens on IVD makers to promote faster availability of clinical laboratory tests.

According to FDA, the new draft guidance will replace the 2003 guidance when finalized, and has been updated to include concepts and recommendations from the agency's recent final guidance on when to submit a new 510(k) for changes to a cleared device.

FDA also says it will open up the policy to include some diagnostics that were previously precluded from the replacement reagent and instrument family policy in device specific guidance or through special controls on those devices.

So far, FDA says the policy has mostly been used by manufacturers for traditional laboratory automated chemistry and immunoassays, and that manufacturers can use the agency's pre-submission process to get feedback on whether the policy is applicable to their assays.


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