Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices: Guidance for Industry and Food and Drug Administration Staff

Name: Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices: Guidance for Industry and Food and Drug Administration Staff
Creator: Food and Drug Administration
Keywords: amendments,applications,diagnostics,guidances,in-vitro-diagnostic-devices,in-vitro-diagnostics,industry,ivd,ivd-devices,laboratories,manufacturers,recommendations,waiver

Information

Type

Guidance

Regulated products

Biologics, IVDMD, Medical Devices

Published

February 26, 2020

Last updated

August 9, 2024

Description

This document provides guidance for manufacturers of in vitro diagnostic devices on Clinical Laboratory Improvement Amendments (CLIA) waiver applications.

Organization

Food and Drug Administration (FDA) 🇺🇸

Country / Region

United States

License

Other (Public Domain)

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Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices: Guidance for Industry and Food and Drug Administration Staff

Updated on August 9, 2024

pdf (596.0KB)

URL: https://www.fda.gov/media/109582/download
Permalink: https://data.openrid.co/en/datasets/r/a08cbf4d-3f91-484d-941c-7daa138fd48c
MIME Type: application/pdf

Created on: February 26, 2020
Modified on: August 9, 2024

Size: 596.0KB

Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices: Guidance for Industry and Food and Drug Administration Staff

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Type

Regulated products

Published

Last updated

Description

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Country / Region

License

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