# Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product: Draft Guidance for Industry and Food and Drug Administration Staff - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/principles-for-codevelopment-of-an-in-vitro-companion-diagnostic-device-with-a-therapeutic-product-draft-guidance-for-industry-and-food-and-drug-administration-staff/4ce3b99f-f096-4bd8-987d-0240d96508d2

> FDA guidance document: Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product: Draft Guidance for Industry and Food and Drug Administration Staff. Issue date: July 15, 2016. Get complete insights and analysis.

---

## Details

- Title: Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product: Draft Guidance for Industry and Food and Drug Administration Staff
- Communication Type: Guidance Document
- Product Type: devices
- Office Name: Center for Devices and Radiological Health
- Office URL: /offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7
- Issue Date: 2016-07-15
- Comment Close Date: 2016-10-13
- Last Changed: 2019-05-14
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2016-D-1703">FDA-2016-D-1703</a>

## Related Documents

- [Hernia Mesh – Package Labeling Recommendations: Draft Guidance for Industry and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/hernia-mesh-package-labeling-recommendations-draft-guidance-for-industry-and-food-and-drug-administration-staff/f3f2df12-07bc-40dd-9050-853b9e9e58a8)
- [Medical Devices with Indications Associated with Weight Loss - Clinical Study and Benefit-Risk Considerations: Draft Guidance for Industry and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/medical-devices-with-indications-associated-with-weight-loss-clinical-study-and-benefit-risk-considerations-draft-guidance-for-industry-and-food-and-drug-administration-staff/1bd2627c-f33e-4f60-abd9-edb7104aa188)
- [List of Highest Priority Devices for Human Factors Review: Draft Guidance for Industry and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/list-of-highest-priority-devices-for-human-factors-review-draft-guidance-for-industry-and-food-and-drug-administration-staff/0dc7b489-3bcc-4d2a-b052-209e46552610)