Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect Bacterial Protease Activity in Chronic Wound Fluid

The Food and Drug Administration (FDA, the Agency, or we) is classifying the device to detect bacterial protease activity in chronic wound fluid 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 device to detect bacterial protease activity in chronic wound fluid's 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.