- For immediate release:
The US Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 pandemic:
- On Oct. 12, the FDA posted information about a review of the Emergency Use Authorization (EUA) process that the FDA’s Center for Devices and Radiological Health (CDRH) has implemented to authorize COVID-19 testing during the emergency in the area. of public health. The assessment was conducted by Booz Allen Hamilton, an independent third-party contractor. This review focuses on how CDRH prioritized EUA request processing, assessment times, accuracy and reliability of COVID-19 testing, a comparison with past public health emergencies, and applicants’ perspectives. The web posting includes Booz Allen Hamilton’s Emergency Use Authorization Assessment and recommendations and CDRH’s perspectives and next steps.
- The Center for Food Safety and Applied Nutrition has published a Constituent Update aimed at workers in the food, agricultural and industrial sectors to encourage flu and COVID-19 vaccination.
- Testing updates:
- As of today, 418 tests and sample collection devices have been approved by the FDA under emergency approvals (EUAs). These include 292 molecular tests and sample collection devices, 89 antibody and other immune response tests, and 37 antigen tests. There are 66 molecular authorizations and one antibody authorization that can be used with self-collected samples. There is one prescription molecular home test, three prescription home antigen tests, seven antigen over-the-counter (OTC) self-tests, and two OTC home molecular tests.
- The FDA has approved 16 antigen tests and eight molecular tests for serial screening programs. The FDA has also approved 650 revisions to EUA authorizations.
The FDA, an agency within the United States Department of Health and Human Services, protects public health by ensuring the safety, effectiveness, and security of human and animal medicines, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our country’s food supply, cosmetics, nutritional supplements, products that emit electronic radiation, and for regulating tobacco products.