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# Draft Guide on Companion Diagnostics
- URL: https://www.fdaweb.com/draft-guide-on-companion-diagnostics/
- Published: 2018-12-07T12:00:00.000Z
- Updated: 2026-09-15T00:49:29.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5142987

*Federal Register* notice: FDA has made available a draft guidance entitled “Developing and Labeling *In Vitro* Companion Diagnostic Devices for a Specific Group or Class of Oncology Therapeutic Products.” The document includes factors for considering when broader labeling of a companion diagnostic would be appropriate. It notes that oncology companion diagnostics with broader evidence-based indications will optimally facilitate clinical use. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-12-07/pdf/2018-26554.pdf?ref=fdaweb.com).