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

Name: 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
Creator: Food and Drug Administration
Keywords: applications,approval,exemptions,guidances,industry,investigational-device-exemption,investigational-devices,pma,pre-market,pre-market-approval,pre-market-authorization

Information

Type

Guidance

Regulated products

Medical Devices

Topics

Investigational Device Exemption (IDE), Premarket

Published

November 9, 2012

Last updated

February 28, 2020

Description

A guidance document on the content of IDE and PMA applications for artificial pancreas device systems.

Organization

Food and Drug Administration (FDA) 🇺🇸

Country / Region

United States

License

Other (Public Domain)

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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

Updated on February 28, 2020

pdf (688.7KB)

URL: https://www.fda.gov/media/80644/download
Permalink: https://data.openrid.co/en/datasets/r/e6abbc26-7f0a-4996-80de-f79796a82a99
MIME Type: application/pdf

Created on: November 9, 2012
Modified on: February 28, 2020

Size: 688.7KB

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

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Type

Regulated products

Topics

Published

Last updated

Description

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Organization

Country / Region

License

Feedback

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