Predetermined Change Control Plans for Medical Devices: Draft Guidance for Industry and FDA Staff

Name: Predetermined Change Control Plans for Medical Devices: Draft Guidance for Industry and FDA Staff
Creator: Food and Drug Administration
Keywords: changes,draft,fda,guidances,industry,medical-devices,pre-market

Information

Type

Guidance

Regulated products

Medical Devices

Topics

Premarket

Published

August 22, 2024

Last updated

August 22, 2024

Description

Draft guidance document for industry and FDA staff on predetermined change control plans for medical devices in the premarket phase.

Organization

Food and Drug Administration (FDA) 🇺🇸

Country / Region

United States

License

Other (Public Domain)

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1 Main file

Predetermined Change Control Plans for Medical Devices: Draft Guidance for Industry and FDA Staff

Updated on August 22, 2024

pdf (1.4MB)

URL: https://www.fda.gov/media/180978/download
Permalink: https://data.openrid.co/en/datasets/r/b1ce3437-1f3b-4879-b685-7272ba723ec0
MIME Type: application/pdf

Created on: August 22, 2024
Modified on: August 22, 2024

Size: 1.4MB

Predetermined Change Control Plans for Medical Devices: Draft Guidance for Industry and FDA Staff

Information

Type

Regulated products

Topics

Published

Last updated

Description

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Country / Region

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