Senate looks to expand rules on reprocessed SUDs (single-use medical devices)
This article was originally published in Clinica
Executive Summary
Senate appropriators are proposing two major changes in how FDA regulates reprocessed single-use medical devices (SUDs). The report on the Senate Appropriations Committee's fiscal year 2003 spending bill for the US FDA calls on the agency to require a premarket submission for every model of SUD that is to be reprocessed.