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# Replacement Reagent Instrument Family Policy Guidance
- URL: https://www.fdaweb.com/replacement-reagent-instrument-family-policy-guidance/
- Published: 2022-08-16T12:00:00.000Z
- Updated: 2026-09-14T17:56:00.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5152513

FDA has published a guidance, *Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices*, updating a 2003 updated guidance. The latest [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/replacement-reagent-and-instrument-family-policy-in-vitro-diagnostic-devices?utm%5Fmedium=email&utm%5Fsource=govdelivery) says the 2003 guidance described a mechanism for manufacturers to follow when applying an assay that was previously cleared based on performance characteristics when used with a specified instrument to an additional instrument that is either cleared or a member of an instrument family from which another instrument was previously cleared.

The agency says the latest update is intended to provide clarity on the policy for manufacturers of in vitro diagnostics to promote consistent application of the guidance’s concepts. The guidance also incorporates concepts and recommendations from several other related guidances.

The contents of the new guidance include Introduction, Scope, Replacement Reagent Policy, Instrument Family Policy, Examples, Labeling, Clinical Laboratory Improvement Amendments Categorization, and two appendices.