
FDA Regulations on Monkeypox Rapid Antigen Test Kits EUA Applications
In August 2022, the Secretary of the U.S. Department of Health and Human Services (HHS) declared an Emergency Use Authorization (EUA) for diagnostic tests for

In August 2022, the Secretary of the U.S. Department of Health and Human Services (HHS) declared an Emergency Use Authorization (EUA) for diagnostic tests for

As a clinical research center, we aim to evaluate many of the medical and surgical inventions used today to ensure that medications, medical devices, and

When a medical device has not been approved for marketing in the U.S. or has been approved but is still undergoing clinical evaluation, it is