Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics : Guidance for Stakeholders and Food and Drug Administration Staff

Name: Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics : Guidance for Stakeholders and Food and Drug Administration Staff
Creator: Food and Drug Administration
Keywords: databases,diagnostics,genetic,guidances,in-vitro-diagnostics,ivd,support,validity

Information

Type

Guidance

Regulated products

IVDMD, Medical Devices

Topics

Premarket

Published

April 13, 2018

Last updated

April 9, 2019

Description

This document provides guidance on using public genetic variant databases to support clinical validity for in vitro diagnostics.

Organization

Food and Drug Administration (FDA) 🇺🇸

Country / Region

United States

License

Other (Public Domain)

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Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics : Guidance for Stakeholders and Food and Drug Administration Staff

Updated on April 9, 2019

pdf (593.1KB)

URL: https://www.fda.gov/media/99200/download
Permalink: https://data.openrid.co/en/datasets/r/97789db0-cc2f-45c5-ac4c-e62afdd08746
MIME Type: application/pdf

Created on: April 13, 2018
Modified on: April 9, 2019

Size: 593.1KB

Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics : Guidance for Stakeholders and Food and Drug Administration Staff

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