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FDAnews Device Daily Bulletin

FDA Issues Decision on PreMD’s Cholesterol Test

Jan. 17, 2008

Canadian devicemaker PreMD has received a nonsubstantially equivalent letter from the FDA regarding its 510(k) submission for an expanded regulatory claim on a point-of-care skin cholesterol test.

The agency’s basis for rejecting the claim relates to the clinical utility of evaluating skin cholesterol with carotid wall intima thickness as the clinical endpoint.

The study design PreMD submitted in its June 2007 application was initially considered appropriate by the FDA. The agency subsequently requested additional information regarding statistical clarification on the data submitted, which the company said it provided.