# Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group of Oncology Therapeutic Products: Guidance for Industry - FDA Guidance Document Source: https://www.globalkeysolutions.net/guidances/guidance-document/developing-and-labeling-in-vitro-companion-diagnostic-devices-for-a-specific-group-of-oncology-therapeutic-products-guidance-for-industry/82ea240f-dc2b-46d0-ae91-99195d7be074 > FDA guidance document: Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group of Oncology Therapeutic Products: Guidance for Industry. Issue date: April 13, 2020. Get complete insights and analysis. --- ## Details - Title: Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group of Oncology Therapeutic Products: Guidance for Industry - Communication Type: Guidance Document - Product Type: devices - Office Name: Office of the Commissioner - Office URL: /offices/office-of-the-commissioner/79483979-9582-427f-ac3d-46c715811424 - Issue Date: 2020-04-13 - Comment Close Date: 2019-02-05 - Last Changed: 2020-04-13 - Docket Number: FDA-2018-D-3380 ## Related Documents - [Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/investigational-in-vitro-diagnostics-in-oncology-trials-streamlined-submission-process-for-study-risk-determination-guidance-for-industry/ff9a397a-14c7-475f-9b86-e658211b0705) - [E18 Genomic Sampling and Management of Genomic Data Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/e18-genomic-sampling-and-management-of-genomic-data-guidance-for-industry/72ee1cb4-40ce-4946-a9c9-427e4bbb21d6) - [Use of Electronic Health Record Data in Clinical Investigations Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/use-of-electronic-health-record-data-in-clinical-investigations-guidance-for-industry/165621f1-dbb5-4b0f-a30a-c5d0ea2e7d02)