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Pressure for over-the-counter (OTC) sales of Sensor Pad:

This article was originally published in Clinica

Executive Summary

Nevada Congresswoman Barbara Vucanovich is trying to force the FDA to allow over-the-counter sales of Inventive Products' Sensor Pad breast self-examination device. If she succeeds, this will be the first time Congress has ever ordered approval in any status of a medical device. After years of controversy, the FDA approved the device several months ago (see Clinica No 687, p 16) - but has refused to allow non-prescription marketing of the silicone-filled device. Ms Vucanovich's legislation has not been assigned to any committee and action this year is unlikely.





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