🧬FDA Classifies Cancer Predisposition Risk Assessment Systems
Medical Devices; Immunology and Microbiology Devices; Classification of the Cancer Predisposition Risk Assessment System
Summary
The Food and Drug Administration (FDA, the Agency, or we) is classifying the cancer predisposition risk assessment system 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 cancer predisposition risk assessment system. 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
$$$ - High
This regulatory text details the classification of the cancer predisposition risk assessment system into class II, which entails specific compliance and regulatory requirements for businesses involved in medical devices. It outlines the controls necessary to ensure safety and effectiveness, significantly impacting market access and burden reduction for businesses.