Document published by the source itself
In Vitro Companion Diagnostic Devices
FDA guidance page for developers of therapeutic products and corresponding in vitro companion diagnostic devices.
Technical guidanceU.S. Food and Drug Administration
Source
This guidance is intended to assist (1) sponsors who are planning to develop a therapeutic product1 (either a novel product or an existing product with a new indication)
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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Automated source verification
2026-10-18
2026-10-19
professional use
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