# Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies:  Guidance for Industry and Food and Drug Administration Staff - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/investigational-device-exemptions-ides-for-early-feasibility-medical-device-clinical-studies-including-certain-first-in-human-fih-studies-guidance-for-industry-and-food-and-drug-administration-staff/4cd54e2e-d8ae-4587-9c8b-defde57aa5e1

> FDA guidance document: Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies:  Guidance for Industry and Food and Drug Administration Staff. Issue date: October 01, 2013. Get complete insights and analysis.

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## Details

- Title: Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies:  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: 2013-10-01
- Last Changed: 2020-02-28
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2011-D-0787">FDA-2011-D-0787</a>

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