# Investigational IVDs Used in Clinical Investigations of Therapeutic Products: Draft Guidance for Industry, Food and Drug Administration Staff, Sponsors, and Institutional Review Boards - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/investigational-ivds-used-in-clinical-investigations-of-therapeutic-products-draft-guidance-for-industry-food-and-drug-administration-staff-sponsors-and-institutional-review-boards/4238dfca-183e-4815-977e-a5fc2f0a83c0

> FDA guidance document: Investigational IVDs Used in Clinical Investigations of Therapeutic Products: Draft Guidance for Industry, Food and Drug Administration Staff, Sponsors, and Institutional Review Boards. Issue date: December 18, 2017. Get complete insights and analysis.

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## Details

- Title: Investigational IVDs Used in Clinical Investigations of Therapeutic Products: Draft Guidance for Industry, Food and Drug Administration Staff, Sponsors, and Institutional Review Boards
- 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: 2017-12-18
- Comment Close Date: 2018-03-19
- Last Changed: 2020-03-02
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2017-N-6356">FDA-2017-N-6356</a>

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