Off-label advertising and sale of COVID-19 rapid antigen tests under workplace screening initiative: Interim enforcement approach

MDEL Bulletin, June 15, 2021, from the Medical Devices Compliance Program

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Rapid antigen tests and the workplace screening initiative

There are currently various technologies to detect SARS CoV-2, the virus that causes COVID-19. Antigen-based testing devices detect specific proteins on the surface of the virus and typically provide results in less than 1 hour. While some rapid antigen detection tests (RADTs) have been approved for people without symptoms, most RADTs are indicated for use on people with symptoms and are to be conducted by laboratory personnel, healthcare professionals or trained operators.

Health Canada has authorized several RADTs under two interim orders:

The indications and conditions of use of authorized products may change over time as manufacturers continue to collect data.

Screening asymptomatic individuals for SARS CoV-2 is proving to be effective in high-risk settings where social distancing and other measures are not feasible.

Through the workplace screening initiative, Canada is supplying RADTs to eligible workplaces across the country. The initiative will help companies detect early cases of COVID-19, for people who are asymptomatic. This initiative is being administered in collaboration with the provinces and territories.

Interim enforcement approach

In the interest of public health, Health Canada is placing less priority on enforcing off-label distribution of RADTs under the following circumstances:

This enforcement discretion will be in effect until December 31, 2021. The exception is if:

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