General and Plastic Surgery Devices: Proposed Classification for the Tissue Expander
Information
Type
Proposed Rule
Regulated products
Published
December 22, 2008
Last updated
December 22, 2008
Description
Document number E8-30439. The Food and Drug Administration (FDA) is proposing to classify into class II (special controls) the tissue expander, as a device intended for temporary (less than 6 months) subdermal implantation to stretch the skin for surgical applications, specifically to develop surgical flaps and additional tissue coverage. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the draft guidance that FDA intends will serve as the special control if FDA classifies this device type into class II.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)