Zdrowie i gospodarka · 22/12/2008

FDA Proposes Classification of Tissue Expanders as Class II Devices

The Food and Drug Administration (FDA) is proposing to classify tissue expanders as Class II devices, intended for temporary subdermal implantation to stretch skin for surgical applications, such as developing surgical flaps and additional tissue coverage, with a proposed classification period of less than 6 months. The FDA also announced the availability of a draft guidance document that will serve as the special control if the device is classified into Class II.