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Regulatory News In Brief

This article was originally published in The Gray Sheet

Executive Summary

Silicone sheeting exemption proposed: FDA would make silicone sheeting intended to treat intact hyperproliferative skin (for the management of keloid and hypertrophic scars) nonprescription Class I exempt devices under a proposed rule published in the Federal Register March 20. In July 2002, the agency's General & Plastic Surgery Devices Panel voted that the devices should be Class I, but suggested FDA require 510(k) clearance and prescription status (1"The Gray Sheet" July 15, 2002, p. 5). In the 2silicone sheeting proposed rule, FDA points out that several classes of wound dressing products applied to non-intact skin are Class I exempt and nonprescription. Similar controls should be adequate for silicone sheeting since it is applied to intact skin, the agency argues. Comments are due by June 18...
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