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Fig. 2 | Genome Medicine

Fig. 2

From: Whole-genome sequencing as an investigational device for return of hereditary disease risk and pharmacogenomic results as part of the All of Us Research Program

Fig. 2

Timeline of the IDE application process. The requirements for the investigational device exemption (IDE) content were refined through a series of pre-IDE submissions and responses, in-person meetings, and teleconferences with the United States Food and Drug Administration (FDA) over a period of 19 months. AoURP, All of Us Research Program; CCP, Change Control Policy; IC, informed consent; PGx, pharmacogenomics; Pre-Sub, pre-submission; SR, significant risk; Sup, supplement

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Genome Medicine

ISSN: 1756-994X

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