🧪FDA Classifies Anti-Phospholipase A2 Receptor Test System
Medical Devices; Immunology and Microbiology Devices; Classification of the Anti-Phospholipase A2 Receptor Immunological Test System
Summary
The Food and Drug Administration (FDA, the Agency, or we) is classifying the anti-phospholipase A2 receptor immunological test 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 the anti-phospholipase A2 receptor immunological test system's classification. 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
The regulation classifies a medical device (anti-phospholipase A2 receptor test system) into class II, streamlining the approval process and reducing regulatory burdens for manufacturers. This can lead to increased market entry opportunities and potential revenue growth. Compliance with specific special controls and premarket notification requirements outlines regulatory expectations for businesses in this sector.