# Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination Guidance for Industry - FDA Guidance Document

Source: 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

> FDA guidance document: Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination Guidance for Industry. Issue date: October 10, 2019. Get complete insights and analysis.

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## Details

- Title: Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination Guidance for Industry
- Communication Type: Guidance Document
- Product Type: drugs
- Office Name: Center for Drug Evaluation and Research
- Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c
- Issue Date: 2019-10-10
- Last Changed: 2020-04-24
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2018-D-0944">FDA-2018-D-0944</a>

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