OTC COVID-19 Tests Without Clearance For Sales Smuggled Into US
Korean firm investigating how the test was imported and “strengthening contract terms and their enforcement” with distributors to curb “further attempts at illegal importation.” FDA granted an EUA in December for a different test made by firm.
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FDA releases information about reporting results of OTC at-home COVID-19 antigen tests, as well as recommendations on who should get tested, when and how often.
Counterfeit versions of diagnostics from ACON Laboratories and iHealth are being illegally imported and sold in US. Alert also tells consumers how to spot counterfeit tests.
Medicare traditionally has not covered OTC tests but CMS says importance of testing in fighting pandemic changed its calculus.