Medical Devices; General and Plastic Surgery Devices; Classification of Tissue Adhesive With Adjunct Wound Closure Device Intended for Topical Approximation of Skin
Information
Type
Rule
Regulated products
Medical Devices
Published
November 10, 2010
Last updated
November 10, 2010
Description
Document number 2010-28356. The Food and Drug Administration (FDA) is classifying the tissue adhesive with adjunct wound closure device intended for topical approximation into class II (special controls). The special control that will apply to the device is the guidance document entitled "Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Tissue Adhesive With Adjunct Wound Closure Device Intended for the Topical Approximation of Skin." The agency is classifying the device into class II (special controls) in order to provide reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special control for this device type.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)