federal_register: 2022-02369

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2022-02369 Medical Devices; General Hospital and Personal Use Devices; Classification of the Alternate Controller Enabled Infusion Pump Rule The Food and Drug Administration (FDA, Agency, or we) is classifying the alternate controller enabled infusion pump 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 alternate controller enabled infusion pump'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. 2022-02-04 2022 2 https://www.federalregister.gov/documents/2022/02/04/2022-02369/medical-devices-general-hospital-and-personal-use-devices-classification-of-the-alternate-controller https://www.govinfo.gov/content/pkg/FR-2022-02-04/pdf/2022-02369.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA, Agency, or we) is classifying the alternate controller enabled infusion pump into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of...

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