# The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Artificial Pancreas Device Systems:  Guidance for Industry and Food and Drug Administration Staff - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/the-content-of-investigational-device-exemption-ide-and-premarket-approval-pma-applications-for-artificial-pancreas-device-systems-guidance-for-industry-and-food-and-drug-administration-staff/692e0ca7-0e58-43e0-92f6-1f2f471e307d

> FDA guidance document: The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Artificial Pancreas Device Systems:  Guidance for Industry and Food and Drug Administration Staff. Issue date: November 09, 2012. Get complete insights and analysis.

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## Details

- Title: The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Artificial Pancreas Device Systems:  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: 2012-11-09
- Last Changed: 2020-02-28
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2011-D-0464">FDA-2011-D-0464</a>

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