Testing devices for COVID-19: Test swabs safety and effectiveness guidance

Testing devices for COVID-19: Test swabs safety and effectiveness guidance This guidance document presents the criteria for safety and effectiveness that apply to test swabs used for COVID-19 sampling. It also provides guidance on how to meet these criteria in an application under the IO pathway. 2020-11-04 Health Canada open-ouvert@tbs-sct.gc.ca Health and SafetyCOVID-19pandemictesting devicestest swabssamplingcriteria for safety and effectiveness Testing devices for COVID-19: Test swabs safety and effectiveness guidanceHTML https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/medical-devices/testing/test-swabs.html Testing devices for COVID-19: Test swabs safety and effectiveness guidanceHTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/covid19-industrie/instruments-medicaux/depistage/tests-depistage.html

This guidance document presents the criteria for safety and effectiveness that apply to test swabs used for COVID-19 sampling. It also provides guidance on how to meet these criteria in an application under the IO pathway.

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