🧪FDA Classifies Anti-Phospholipase A2 Receptor Test System
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.
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The National Institute of Allergy and Infectious Diseases has announced a closed meeting to evaluate grant applications for clinical trials. The meeting, following federal regulations for confidentiality, focuses on reviewing potential funding for research projects in allergy and infectious diseases, thereby impacting grant seekers in these fields.
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