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

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

Collection:
Health Policy and Services Research
Series Title(s):
Guidance for industry
Contributor(s):
United States. Department of Health and Human Services, issuing body.
United States. Food and Drug Administration, issuing body.
Center for Biologics Evaluation and Research (U.S.), issuing body.
Center for Devices and Radiological Health (U.S.), issuing body.
Publication:
Silver Spring, MD : Center for Devices and Radiological Health, April 13, 2018
Language(s):
English
Format:
Text
Subject(s):
Databases, Genetic
Reagent Kits, Diagnostic -- standards
Reproducibility of Results
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
Genre(s):
Guideline
Technical Report
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (16 pages)).
NLM Unique ID:
101734132 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/101734132