🐖Proposed Changes to Swine Slaughter Inspection Regulations
FSIS is proposing to end mandatory mandibular lymph nodes incision and viscera palpation of swine carcasses in all swine slaughter establishments (i.e., establishments operating under traditional swine slaughter inspection or the New Swine Slaughter Inspection System (NSIS). Mandibular lymph nodes ("lymph nodes") incision and viscera palpation of swine carcasses are not needed to ensure food safety, as FSIS swine condemnation rates are low and disease conditions that are condemnable defects can be detected visually through other pathological changes in the carcass and its parts. Therefore, FSIS is proposing to amend the meat inspection regulations to remove requirements for establishment sorters to "incise mandibular lymph nodes and palpate the viscera" as part of their sorting activities before FSIS post-mortem inspection in NSIS establishments. FSIS is also proposing to amend the post-mortem swine inspection staffing standards table applicable to swine slaughter establishments operating under traditional inspection. This change would allow FSIS more flexibility to assign inspection program personnel (IPP) based on the establishment's line configuration, other establishment operations, and FSIS staffing needs.
Learn More🧬FDA Classifies Fluorescence Devices for Hematologic Malignancies
The Food and Drug Administration (FDA, the Agency, or we) is classifying the fluorescence in situ hybridization-based detection of chromosomal abnormalities from patients with hematologic malignancies 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 fluorescence in situ hybridization-based detection of chromosomal abnormalities from patients with hematologic malignancies' classification. We are taking this action because we have determined that classifying the device into class II (special controls) 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.
Learn More🧬FDA Proposes Reclassification of Hematology Devices Affecting ISH Systems
The Food and Drug Administration (FDA) is proposing to reclassify in situ hybridization (ISH) test systems indicated for use with a corresponding approved oncology therapeutic product (product codes NYQ, MVD, OWE, and PNK) from class III (premarket approval) into class II (special controls), subject to premarket notification. FDA is also proposing a new device classification regulation, along with the special controls that FDA believes are necessary to provide a reasonable assurance of safety and effectiveness for this device type.
Learn More⚙️FDA Classifies Coagulation System for Blood Measurement Devices
The Food and Drug Administration (FDA, Agency, or we) is classifying the coagulation system for the measurement of whole blood viscoelastic properties in perioperative patients 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 coagulation system for the measurement of whole blood viscoelastic properties in perioperative patients' classification. We are taking this action because we have determined that classifying the device into class II (special controls) 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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