Documento fuente o registro público

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

Fuente

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)
fda.gov · Consultado el 2026-10-19

Esta entrada describe lo que cubre el documento; el propio documento es la autoridad. Incluirlo no implica estar de acuerdo con sus conclusiones.

Review and references

Reviewer

Automated source verification

Published

2026-10-18

Updated

2026-10-20

Disclaimer

professional use

References

In Vitro Companion Diagnostic Devices

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