Fed Regist. 2010 Nov 17;75(221):70112-4.
The Food and Drug Administration (FDA) is classifying the non-powered suction apparatus device intended for negative pressure wound therapy (NPWT) into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Non-Powered Suction Apparatus Device Intended for Negative Pressure Wound Therapy." The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability for the guidance document entitled "Class II Special Controls Guidance Document: Non-Powered Suction Apparatus Device Intended for Negative Pressure Wound Therapy."
美国食品药品监督管理局（FDA）正在将用于负压伤口治疗（NPWT）的非电动吸引装置归类为II类（特殊控制）。适用于该装置的特殊控制是题为《II类特殊控制指南文件：用于负压伤口治疗的非电动吸引装置》的指南文件。该机构将该装置归类为II类（特殊控制），以便合理保证该装置的安全性和有效性。在本期《联邦公报》的其他地方，FDA发布了一份题为《II类特殊控制指南文件：用于负压伤口治疗的非电动吸引装置》的指南文件可用性通知。
