💉FDA Classifies X-Ray Attenuation Cream Under Class II Devices
Medical Devices; Radiology Devices; Classification of the Cream for X-Ray Attenuation
Summary
The Food and Drug Administration (FDA, the Agency, or we) is classifying the cream for x-ray attenuation 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 cream for x-ray attenuation'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 the cream for x-ray attenuation as Class II (special controls), affecting compliance and product development for manufacturers. It outlines specific safety and effectiveness testing requirements and labeling standards that businesses must follow to ensure market access.