- For immediate release:
The United States Food and Drug Administration today announced the following actions taken as part of its ongoing response efforts to the COVID-19 pandemic:
- The FDA has taken creative and flexible approaches to manage the availability of critical medical products in response to COVID-19. In addition, non-traditional manufacturers and community responders have helped fill shortages and gaps in medical supplies during the COVID-19 pandemic, and have provided millions of equipment and supplies, such as masks, screens. facial and other 3D printed medical devices. In September 2020, the FDA funded a study, conducted by America Makes, to summarize the impact of 3D printing on the overall response to COVID-19. The FDA has now released this report on the use of additive manufacturing by non-traditional producers in support of the U.S. COVID-19 response. The study shows the successes, challenges and key lessons learned to leverage and improve future crisis response. The FDA is reviewing the report to assess gaps in response and potential mitigation measures for future public health emergencies.
- The FDA has issued Emergency Use Authorization (EUA) to Ortho-Clinical Diagnostics, Inc., for the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Test. Quantitative serological tests traceable to a certified reference material may be useful for ongoing medical research to study the immune response to SARS-CoV-2. The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Test measures IgG antibodies against SARS-CoV-2, the virus that causes COVID-19, from a blood sample (serum and plasma) from an individual to help identify individuals with an immune response to SARS-CoV-2, indicating recent or previous infection with SARS-CoV-2.
- As part of the FDA’s efforts to protect consumers, the agency sent warning letters to 12 companies for offering falsified tests, face masks, respirators and surgical masks for sale in the United States. and mislabeled, some of which are intended for use in the mitigation, prevention, treatment, diagnosis or cure of COVID-19 in people. Consumers concerned about COVID-19 should consult their health care provider. Companies that have received warning letters are:
- On July 8, 2021, the FDA hosted a Grand Rounds Conference on FDA Funded Regulatory Scientific Research: SARS-CoV-2 Host-Pathogen Interaction, Vaccines & Variants of Concern. This conference discussed work from two FDA Medical Countermeasures Initiative (MCMi) projects analyzing coronavirus samples to help inform the development of COVID-19 medical countermeasures, led by Public Health England and the University of Liverpool. A webcast recording is available.
- Testing updates:
- To date, 395 tests and specimen collection devices have been approved by the FDA under Emergency Use Authorizations (EUA). These include 282 molecular tests and specimen collection devices, 84 antibody tests and other immune response tests, and 29 antigen tests. There are 52 molecular clearances and one antibody clearance that can be used with home samples. There is one home molecular prescription test, three home antigen prescription tests, five over the counter (OTC) home antigen tests, and two over the counter home molecular tests.
- The FDA has authorized 11 antigen tests and six molecular tests for serial screening programs. The FDA has also cleared 561 reviews of EUA authorizations.
The FDA, an agency of the U.S. Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of drugs, vaccines, and other biologicals for human and veterinary use, as well as medical devices. . The agency is also responsible for the safety and security of our country’s food supply, cosmetics, dietary supplements, products that emit electronic radiation, and the regulation of tobacco products.