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# Final Guide on Replacement Reagent for IVDs
- URL: https://www.fdaweb.com/final-guide-on-replacement-reagent-for-ivds/
- Published: 2022-08-18T12:00:00.000Z
- Updated: 2026-09-14T17:56:26.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5152536

*Federal Register* notice: FDA is making available a final guidance entitled “Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices.” The document addresses a manufacturer’s application for an assay that was previously cleared for use based on performance characteristics when used with a specified instrument to an additional instrument that was previously cleared, or that is a member of an instrument family from which another member has been previously cleared. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2022-08-17/pdf/2022-17643.pdf?ref=fdaweb.com).