WebManufacturers following the FDA guidance for molecular and antigen tests for non-laboratory use should note that Health Canada expects them to follow the guidance for non-prescription testing. ... If you plan to request authorization to test specimens collected with a home specimen ... Please contact [email protected] to discuss ... WebJun 30, 2024 · For more information on FDA’s policies and recommendations, see FDA’s Policy for COVID-19 Tests, FDA’s Molecular Diagnostic Template for Laboratories, and FDA’s FAQs on Testing for SARS-CoV-2. Questions about regulatory requirements for COVID-19 diagnostics may be submitted to FDA at [email protected].

At-Home OTC COVID-19 Diagnostic Tests FDA

WebApr 2, 2024 · The FDA notes that this template “applies to developers of molecular and antigen tests, for use in serial testing programs, as well as at-home tests for use in a serial manner outside of a testing program, intended to detect SARS-CoV-2 from individuals without symptoms or other epidemiological reasons to suspect COVID-19 infection.” fact symposium

Updated: FDA smooths the path for COVID screening tests

WebNov 4, 2024 · Nine months later, on November 17, 2024, the first EUA for a home COVID-19 test, in this case a molecular test, was issued and the first EUA for a home antigen test was issued December 15, 2024 ... WebJul 30, 2024 · The Food and Drug Administration (FDA) has published a new template for emergency at-home and over-the-counter diagnostic … WebFood and Drug Administration (FDA) has updated the Healthcare Provider Fact Sheet to reflect more recent authorizations. By submitting this EUA revision for review by the … dog coats and boots for winter