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Regulation requirements change for UroMed device

This article was originally published in Clinica

Executive Summary

UroMed's Reliance urinary control insert requires a PMA, the US FDA has decided, not a 510(k) as originally thought. After 17 months of interaction, the FDA has converted the application to a PMA track. This unusual step was taken because UroMed says it had been incorrectly advised by the FDA to submit a 510(k). The FDA has said it will carry out the review as expeditiously as possible.





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