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"LIMITED PROMOTION" OF UNAPPROVED DEVICES AT TRADE SHOWS

This article was originally published in The Gray Sheet

Executive Summary

"LIMITED PROMOTION" OF UNAPPROVED DEVICES AT TRADE SHOWS would be allowed by FDA under the latest draft of a compliance policy guide governing promotion of devices that are pending premarket approval or 510(k) clearance, according to agency staffers. However, the policy, currently under review by FDA's Office of General Counsel, makes two stipulations regarding disclosure of product status: first, trade show displays must state prominently that the product is awaiting FDA clearance/approval and is not currently being marketed in the U.S., and second, the firm may not claim or suggest that the device is "safe and effective."

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