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MANUFACTURER ABUSE OF IDE REGS TO MARKET DEVICES

This article was originally published in The Gray Sheet

Executive Summary

MANUFACTURER ABUSE OF IDE REGS TO MARKET DEVICES is being probed by the HHS Inspector General's office, according to an updated version of the IG work plan for fiscal year 1995. Under the audit, which was requested by FDA Center for Devices and Radiological Health Director Bruce Burlington, the IG is looking at whether companies are using investigational device exemptions as cover for essentially marketing the products. FDA is concerned the practice may be "pervasive" in the industry, according to agency staffers.
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