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RESTRICTED DEVICE ADVERTISING REG LIKELY TO EXEMPT INSULIN SYRINGES

This article was originally published in The Gray Sheet

Executive Summary

RESTRICTED DEVICE ADVERTISING REG LIKELY TO EXEMPT INSULIN SYRINGES, home use lancets and at least 10 other devices, Byron Tart, director of the Promotion and Advertising Policy staff at FDA's Center for Devices and Radiological Health, said at a Sept. 12 meeting of the Food and Drug Law Institute in Washington, D.C. The syringes and "home diagnosis" lancets are on a preliminary list of 12 devices that, according to an outline of a notice of proposed rulemaking presented by Tart, do not meet the criteria for coverage under the restricted devices regulation.
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