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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| Main Authors: | , |
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| Format: | Article |
| Language: | English |
| Published: |
BioMed Central
2014-12-01
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| Series: | Genomics & Informatics |
| Subjects: | |
| Online Access: | http://genominfo.org/upload/pdf/gni-12-151.pdf |
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