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This article was originally published in The Gray Sheet

Executive Summary

"Preliminary communication" from FDA indicates that the Reliance Insert female urinary incontinence device will require a premarket approval application; UroMed expected to file a 510(k) for the product, which will be its first offering ("The Gray Sheet" Feb. 21, p. 13). The firm may meet with the agency in August to present its 510(k) clinical data and to "seek counsel on the requirements for U.S. marketing approval and for an [investigational device exemption] if it is determined to be necessary." FDA has "indicated" that an expanded or different Reliance clinical trial would require an investigational device exemption, UroMed says



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