Maggots, Leeches And More: Panel Favors Class II Status For Five Devices
This article was originally published in The Gray Sheet
Executive Summary
FDA's General & Plastic Surgery Devices panel voted to make five previously unclassified products Class II devices requiring 510(k) premarket notification Aug. 25 and 26 at a meeting held in Gaithersburg, MD
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Regulatory News In Brief
Tissue expander reclassification: FDA proposes Dec. 19 to classify tissue expanders, temporary subdermal implants that stretch the skin for surgical applications, as Class II with an accompanying draft special controls guidance to help mitigate risks. Tissue expanders were Class III, pre-1976 Medical Device Amendments devices and therefore never subject to PMA review (1"The Gray Sheet" Aug. 29, 2005, p. 9). The devices, made of an inflatable silicone elastomer shell filled with saline, can help create tissue flaps needed for surgical applications such as breast reconstruction or scar revision. Potential risks include skin trauma, device rupture, infection and adverse tissue reaction. Comments are due March 23, 2009