FDA Suggests Sharing OTC COVID-19 Test Results With NIH Program To Help Health Agencies Plan
Executive Summary
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.
You may also be interested in...
First EUA In US For OTC Test To Detect COVID-19, Flu, RSV Granted To Labcorp
Agency issued an emergency use authorization to Labcorp for its OTC that detects COVID-19, flu and respiratory syncytial virus.
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.
FDA’s New Dataset Aims To Assist Labs In Assessing Medical Device Biocompatibility
The US FDA’s device center has unveiled a new public dataset designed to assist chemistry laboratories in ensuring the robustness of chemical characterization methods used to assess the biocompatibility of medical devices.