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GUIDANCE DOCUMENT

Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product Guidance for Industry and Food and Drug Administration Staff July 2016

Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

Docket Number:
FDA-2016-D-1703
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

An in vitro companion diagnostic device (hereafter referred to as an “IVD companion diagnostic”) is an in vitro diagnostic device (IVD) that provides information that is essential for the safe and effective use of a corresponding therapeutic product. As described in the FDA guidance entitled “In Vitro Companion Diagnostic Devices,” in most circumstances, an IVD companion diagnostic should be approved, granted a de novo request or cleared by FDA contemporaneously with the approval of the corresponding therapeutic product for the use indicated in the therapeutic product labeling.

This guidance document is intended to be a practical guide to assist therapeutic product sponsors and IVD sponsors in developing a therapeutic product and an accompanying IVD companion diagnostic, a process referred to as codevelopment. This guidance is also intended to assist FDA staff participating in the review of candidate IVD companion diagnostics or their associated therapeutic products.


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2016-D-1703.