Reflections on the US FDA's Warning on Direct-to-Consumer Genetic Testing

Reflections on the US FDA's Warning on Direct-to-Consumer Genetic Testing

In November 2013, the US Food and Drug Administration (FDA) sent a warning letter to 23andMe, Inc. and ordered the company to discontinue marketing of the 23andMe Personal Genome Service (PGS) until it receives FDA marketing authorization for the device. The FDA considers the PGS as an unclassified...

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Bibliographic Details
Main Authors: Seon-Hee Yim, Yeun-Jun Chung
Format: Article
Language:English
Published: Korea Genome Organization 2014-12-01
Series:Genomics & Informatics
Subjects:
direct-to-consumer genetic testing
medical device
regulation
Online Access:http://genominfo.org/upload/pdf/gni-12-151.pdf

Internet

http://genominfo.org/upload/pdf/gni-12-151.pdf

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