FDAnews Device Daily Bulletin

PreMD: FDA Upholds Previous NSE Decision

Aug. 19, 2008
Predictive medicine company PreMD Inc. announced that the U.S. Food and Drug Administration has upheld their decision regarding the company's not substantially equivalent (NSE) letter it received in January 2008 in connection with its pre-market submission to expand the indication for use of its FDA cleared skin cholesterol test.