federal_register: 2017-24159

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2017-24159 Medical Devices; Immunology and Microbiology Devices; Classification of the Genetic Health Risk Assessment System Rule The Food and Drug Administration (FDA, the Agency, or we) is classifying the genetic health risk assessment system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the genetic health risk assessment system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens. 2017-11-07 2017 11 https://www.federalregister.gov/documents/2017/11/07/2017-24159/medical-devices-immunology-and-microbiology-devices-classification-of-the-genetic-health-risk https://www.govinfo.gov/content/pkg/FR-2017-11-07/pdf/2017-24159.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA, the Agency, or we) is classifying the genetic health risk assessment system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the...

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