federal_register: 2025-10789

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2025-10789 Medical Devices; Radiology Devices; Classification of the Radiological Computer-Assisted Detection and Diagnosis Software Rule The Food and Drug Administration (FDA, the Agency, or we) is classifying the radiological computer-assisted detection and diagnosis software 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 radiological computer-assisted detection and diagnosis software'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. 2025-06-13 2025 6 https://www.federalregister.gov/documents/2025/06/13/2025-10789/medical-devices-radiology-devices-classification-of-the-radiological-computer-assisted-detection-and https://www.govinfo.gov/content/pkg/FR-2025-06-13/pdf/2025-10789.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 radiological computer-assisted detection and diagnosis software into class II (special controls). The special controls that apply to the device type are identified in this...  

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