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23andMe and the FDA: Negotiating Conceptions of Benefit in the Direct-to-Consumer Genetic Testing Regulatory Debate
The oversight and regulation of the direct-to-consumer (DTC) genetic testing industry has been a perennial topic of policy discussion since the emergence of the field in the early 2000s. Despite claiming authority to regulate genetic tests under the 1976 Medical Device Amendments, the U.S. Food and Drug Administration (FDA) ...