FDA Suggests Sharing OTC COVID-19 Test Results With NIH Program To Help Health Agencies Plan
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.
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Agency issued an emergency use authorization to Labcorp for its OTC that detects COVID-19, flu and respiratory syncytial virus.
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.
This week, NIST published a new version of its international cybersecurity standard; SeaStar Medical’s kidney device got an HDE; and the FDA announced safety issues for DT MedTech LLC, operating room tables, and GE incubators.