Off-label advertising and sale of 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:
- interim order No. 1 for importing and selling medical devices (March 18, 2020, to March 1, 2021)
- interim order No. 2 for importing and selling medical devices (enacted March 1, 2021)
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:
- RADTs are provided through the federal government’s workplace screening initiative
- information is provided to participants about the limits of RADTs and that nucleic-acid based testing is the gold standard for diagnosing COVID-19
- testing is administered regularly to employees in accordance with the interim guidance on the use of rapid antigen detection tests for identifying SARS-CoV-2 infection
- administration of the tests follows provincial or territorial guidance (may vary by province/territory)
This enforcement discretion will be in effect until December 31, 2021. The exception is if:
- post-market monitoring identifies new risks or
- there’s no longer a need to apply this discretion based on public health status
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