Medical Devices; Immunology and Microbiology Devices; Classification of the Anti-Phospholipase A2 Receptor Immunological Test System

Document 2025-16031 is a Final Rule published by the Food and Drug Administration in the Federal Register on August 21, 2025, with an effective date of August 21, 2025. 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. View the original at https://www.federalregister.gov/documents/2025/08/21/2025-16031/medical-devices-immunology-and-microbiology-devices-classification-of-the-anti-phospholipase-a2.

No. Document 2025-16031 is not classified as economically significant under Executive Order 12866. Economically significant rules require OIRA review and are estimated to have impacts of $100 million or more per year.