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FDAnews Device Daily Bulletin
Sept. 14, 2012 | Vol. 9 No. 181
IVD License Applications Focus of Health Canada Draft Guidance
Manufacturers of Class III and Class IV in vitro diagnostic (IVD) devices will submit similar clinical and scientific information for summary technical document (STED)-based and non-STED-based license applications and amendments in Canada, according to two draft guidance documents. Aimed at reducing costs and review times, STED-based applications consist of one module for specific Health Canada requirements and a second module to address STED-based requirements. The STED-based component, developed by the Global Harmonization Task Force, requests descriptions for IVDs beyond that required by Health Canada, which must reference a product’s history and/or previous generation.
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