federal_register: 2023-02141

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2023-02141 Medical Devices; Hematology and Pathology Devices; Classification of the Software Algorithm Device To Assist Users in Digital Pathology Rule The Food and Drug Administration (FDA, Agency, or we) is classifying the software algorithm device to assist users in digital pathology 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 software algorithm device to assist users in digital pathology'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. 2023-02-02 2023 2 https://www.federalregister.gov/documents/2023/02/02/2023-02141/medical-devices-hematology-and-pathology-devices-classification-of-the-software-algorithm-device-to https://www.govinfo.gov/content/pkg/FR-2023-02-02/pdf/2023-02141.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA, Agency, or we) is classifying the software algorithm device to assist users in digital pathology into class II (special controls). The special controls that apply to the device type are identified in this order...

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