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# Guidance on Codeveloping IVDs with Therapeutic Products
- URL: https://www.fdaweb.com/guidance-on-codeveloping-ivds-with-therapeutic-products/
- Published: 2016-07-15T12:00:00.000Z
- Updated: 2026-09-14T21:14:49.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5136199

*Federal Register* Notice: FDA is making available a draft guidance entitled *Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product*. It is intended to be a practical guide to assist therapeutic product sponsors and in vitro diagnostic device (IVD) sponsors in developing a therapeutic product with an accompanying IVD companion diagnostic, a process referred to as codevelopment. To download this guidance, click [here](http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM510824?ref=fdaweb.com). To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-07-15/pdf/2016-16735.pdf?ref=fdaweb.com).