💻FDA Final Order on Radiological Computer-Assisted Detection Devices
Medical Devices; Radiology Devices; Classification of the Radiological Computer-Assisted Detection and Diagnosis Software
Summary
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.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The regulation classifies radiological computer-assisted detection and diagnosis software as Class II, reducing regulatory burdens for businesses manufacturing these devices. It outlines compliance requirements and special controls, which affect market entry and operations for medical device companies.