Changes or Modifications During the Conduct of a Clinical Investigation; Final Guidance for Industry and CDRH Staff

Name: Changes or Modifications During the Conduct of a Clinical Investigation; Final Guidance for Industry and CDRH Staff
Creator: Food and Drug Administration
Keywords: cdrh,center-for-devices-and-radiological-health,changes,clinical-investigation,exemptions,guidances,industry,investigation,investigational-device-exemption,investigational-devices,pre-market

Information

Type

Guidance

Regulated products

Medical Devices

Topics

Investigational Device Exemption (IDE), Premarket

Published

May 28, 2001

Last updated

August 10, 2023

Description

Guidance document on changes or modifications during clinical investigations for Investigational Device Exemption (IDE) and Premarket topics.

Organization

Food and Drug Administration (FDA) 🇺🇸

Country / Region

United States

License

Other (Public Domain)

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1 Main file

Changes or Modifications During the Conduct of a Clinical Investigation; Final Guidance for Industry and CDRH Staff

Updated on August 10, 2023

pdf (506.8KB)

URL: https://www.fda.gov/media/72429/download
Permalink: https://data.openrid.co/en/datasets/r/b4204ac4-bb8c-4f00-b60e-897da0db3f39
MIME Type: application/pdf

Created on: May 28, 2001
Modified on: August 10, 2023

Size: 506.8KB

Changes or Modifications During the Conduct of a Clinical Investigation; Final Guidance for Industry and CDRH Staff

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