Premarket approvals (PMA) required for transilluminators
This article was originally published in Clinica
Executive Summary
The US FDA is proposing to classify transilluminators (diaphanoscopes or lightscanners) for breast evaluation as Class III devices. In its proposed rule published in the Federal Register (January 13th), the agency says that distribution of such devices for use in breast tissue contravenes the law and enforcement action has been initiated against manufacturers which have continued to market transilluminators.