federal_register: 2021-26201

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2021-26201 Medical Devices; Anesthesiology Devices; Classification of the Isocapnic Ventilation Device Rule The Food and Drug Administration (FDA or we) is classifying the isocapnic ventilation device 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 isocapnic ventilation device'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. 2021-12-02 2021 12 https://www.federalregister.gov/documents/2021/12/02/2021-26201/medical-devices-anesthesiology-devices-classification-of-the-isocapnic-ventilation-device https://www.govinfo.gov/content/pkg/FR-2021-12-02/pdf/2021-26201.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or we) is classifying the isocapnic ventilation device 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...

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