Investigational Device Exemptions (IDEs) for Devices Indicated for Nocturnal Home Hemodialysis: Guidance for Industry and FDA Staff

Name: Investigational Device Exemptions (IDEs) for Devices Indicated for Nocturnal Home Hemodialysis: Guidance for Industry and FDA Staff
Creator: Food and Drug Administration
Keywords: exemptions,fda,guidances,hemodialysis,industry,investigational-device-exemption,investigational-devices

Information

Type

Guidance

Regulated products

Medical Devices

Topics

Investigational Device Exemption (IDE), Premarket

Published

April 15, 2008

Last updated

March 20, 2020

Description

This document provides guidance for industry and FDA staff on Investigational Device Exemptions (IDEs) for devices used in nocturnal home hemodialysis.

Organization

Food and Drug Administration (FDA) 🇺🇸

Country / Region

United States

License

Other (Public Domain)

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Investigational Device Exemptions (IDEs) for Devices Indicated for Nocturnal Home Hemodialysis: Guidance for Industry and FDA Staff

Updated on March 20, 2020

pdf (196.5KB)

URL: https://www.fda.gov/media/71554/download
Permalink: https://data.openrid.co/en/datasets/r/20acd07a-aa4c-4e03-8a5a-1605f6f9dbfb
MIME Type: application/pdf

Created on: April 15, 2008
Modified on: March 20, 2020

Size: 196.5KB

Investigational Device Exemptions (IDEs) for Devices Indicated for Nocturnal Home Hemodialysis: Guidance for Industry and FDA Staff

Information

Type

Regulated products

Topics

Published

Last updated

Description

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Organization

Country / Region

License

Feedback

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