Medical Devices; General and Plastic Surgery Devices; Classification of Non-Powered Suction Apparatus Device Intended for Negative Pressure Wound Therapy
Information
Type
Rule
Regulated products
Medical Devices
Published
November 17, 2010
Last updated
November 17, 2010
Description
Document number 2010-28873. 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."
Tags
Organization
Country / Region
United States
License
Other (Public Domain)