Home » Canada Loosens Data Requirements for Lab-Destined HIV Test Kits
Canada Loosens Data Requirements for Lab-Destined HIV Test Kits
Developers of laboratory-destined HIV test kits will no longer be required to provide Canadian preclinical and clinical data to support a premarket application in Canada, according to a new draft guidance. However, comparator assays used in clinical studies should be licensed in Canada, the draft says. If a licensed Canadian comparator test is not available, the sponsor may use a reference method or gold standard, as long as the sponsor provides published references supporting the methodology.
International Medical Device Regulatory Monitor
International Medical Device Regulatory Monitor
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