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FDAnews Device Daily Bulletin

PreMD Provides Update on FDA Review

April 14, 2008

The FDA has upheld its decision on PreMD’s appeal of the not substantially equivalent (NSE) letter it received in January for a premarket submission to expand indications for its skin cholesterol test.

In the ruling, the FDA agreed with the company on two of the three issues appealed but concluded that the clinical trial data were not sufficient to determine the product is substantially equivalent to other markers of cardiovascular risk, PreMD said.

PreMD submitted the 510(k) notification in 2007 with the data from a clinical study that was based on guidance received from the FDA in 2004.