🏥FDA Classifies Liver Iron Concentration Imaging Diagnostic
Medical Devices; Radiology Devices; Classification of the Liver Iron Concentration Imaging Companion Diagnostic for Deferasirox
Summary
The Food and Drug Administration (FDA, the Agency, or we) is classifying the liver iron concentration imaging companion diagnostic for deferasirox 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 classification of the liver iron concentration imaging companion diagnostic for deferasirox. We are taking this action because we have determined that classifying the device into class II 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 establishes a new classification for a medical device, which introduces compliance requirements for manufacturers, particularly regarding safety and effectiveness protocols. This affects business owners in the medical device sector as it may alter market entry requirements and regulatory oversight, potentially impacting product development costs and timelines.