Quality System Information for Certain Premarket Application Reviews : Guidance for Industry and FDA Staff

Name: Quality System Information for Certain Premarket Application Reviews : Guidance for Industry and FDA Staff
Creator: Food and Drug Administration
Keywords: applications,fda,guidances,industry,pre-market,quality,quality-systems,review

Information

Type

Guidance

Regulated products

Medical Devices

Topics

Premarket

Published

February 3, 2003

Last updated

March 19, 2020

Description

This document is a guidance for industry and FDA staff on quality system information for certain premarket application reviews.

Organization

Food and Drug Administration (FDA) 🇺🇸

Country / Region

United States

License

Other (Public Domain)

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1 Main file

Quality System Information for Certain Premarket Application Reviews : Guidance for Industry and FDA Staff

Updated on March 19, 2020

pdf (548.0KB)

URL: https://www.fda.gov/media/71083/download
Permalink: https://data.openrid.co/en/datasets/r/cc6d123e-6b79-46f5-bced-8dfd7b545f68
MIME Type: application/pdf

Created on: February 3, 2003
Modified on: March 19, 2020

Size: 548.0KB

Quality System Information for Certain Premarket Application Reviews : Guidance for Industry and FDA Staff

Information

Type

Regulated products

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Published

Last updated

Description

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