🩺FDA Class II Medical Device Classification for Chronic Wound Care
Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect Bacterial Protease Activity in Chronic Wound Fluid
Summary
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.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$$ - High
The regulation classifies a medical device for detecting bacterial protease activity in chronic wound fluid as Class II, which impacts companies developing or marketing similar devices. This classification reduces regulatory burdens, potentially lowering costs and increasing market access. Compliance with special controls detailed in the document is mandatory for device sponsors.