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Source document or public record

Developing and Labeling In Vitro Companion Diagnostic Devices for a Specific Group of Oncology Therapeutic Products

FDA guidance on development and labeling considerations for companion diagnostics intended to support a group of oncology therapeutic products.

Technical guidanceU.S. Food and Drug Administration

Source

This guidance describes considerations for the development and labeling of in vitro companion diagnostic devices

This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.

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Reviewer

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Published

2026-10-18

Updated

2026-10-20

Disclaimer

professional use

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