federal_register: 2020-00497
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2020-00497 | Medical Devices; Radiology Devices; Classification of the Radiological Computer-Assisted Diagnostic Software for Lesions Suspicious for Cancer | Rule | The Food and Drug Administration (FDA or we) is classifying the radiological computer-assisted diagnostic (CADx) software for lesions suspicious for cancer 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 CADx software for lesions suspicious for cancer'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. | 2020-01-22 | 2020 | 1 | https://www.federalregister.gov/documents/2020/01/22/2020-00497/medical-devices-radiology-devices-classification-of-the-radiological-computer-assisted-diagnostic | https://www.govinfo.gov/content/pkg/FR-2020-01-22/pdf/2020-00497.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA or we) is classifying the radiological computer-assisted diagnostic (CADx) software for lesions suspicious for cancer into class II (special controls). The special controls that apply to the device type are... |