Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Guidance for Industry and FDA Staff

Name: Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Guidance for Industry and FDA Staff
Creator: Food and Drug Administration
Keywords: diagnostics,distribution,fda,guidances,in-vitro-diagnostics,industry,ivd,labels,research

Information

Type

Guidance

Regulated products

Biologics, IVDMD, Medical Devices

Topics

Good Clinical Practice (GCP), Investigational Device Exemption (IDE), Premarket

Published

November 25, 2013

Last updated

March 2, 2020

Description

This document provides guidance on the distribution of in vitro diagnostic products labeled for research or investigational use only.

Organization

Food and Drug Administration (FDA) 🇺🇸

Country / Region

United States

License

Other (Public Domain)

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1 Main file

Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Guidance for Industry and FDA Staff

Updated on March 2, 2020

pdf (195.2KB)

URL: https://www.fda.gov/media/87374/download
Permalink: https://data.openrid.co/en/datasets/r/a19055c6-9f0c-490e-90ff-b9b93dd2bc6a
MIME Type: application/pdf

Created on: November 25, 2013
Modified on: March 2, 2020

Size: 195.2KB

Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Guidance for Industry and FDA Staff

Information

Type

Regulated products

Topics

Published

Last updated

Description

Tags

Organization

Country / Region

License

Feedback

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