US FDA Remains Concerned About OTC Access To COVID-19 Tests After It Allows First 'At-Home' Use
OTC access to any test to diagnose COVID-19 without supervision by a health care professional isn't on the near-term horizon for potential launches in the US. In addition to diagnostic kits, digital apps available to directly to consumers for COVID-19 testing on their own would face a steep climb to approval.
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Access Bio’s CareStart COVID-19 Antigen test gives results within 10 minutes, Becton, Dickinson’s BD Veritor within 15 minutes and InBios International’s SCoV-2 Ag Detect within 20 minutes.
One stool sample kit and three serology tests are identified in the agency’s latest warning on OTC sales of unapproved COVID-19 tests. One of the warned firm continues offering sales of its violative product.
House appropriators don’t mention the consumer health market in requesting a report on FDA’s response to COVID-19, but the agency’s frequent warnings about products marketed with unlawful claims could merit mentioning. Encouraging accelerated production of hand sanitizers while also ensuring the additional supplies are safe is another component of its COVID-19 response that could be covered in an assessment of its response to the pandemic.