- For Immediate Release:
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
- The FDA has taken creative and flexible approaches to address availability of critical medical products in response to COVID-19. In addition, non-traditional manufacturers and community responders have helped address shortages and gaps in medical supplies during the COVID-19 pandemic, and yielded millions of pieces of equipment and supplies, such as masks, face shields 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 COVID-19 response. The FDA has now made publicly available this report on the use of additive manufacturing by non-traditional producers in support of the U.S. COVID-19 response. The study shows successes, challenges and key lessons learned to build on and improve future crisis response. The FDA is reviewing the report to assess gaps in the response and potential mitigations for future public health emergencies.
- The FDA issued an Emergency Use Authorization (EUA) to Ortho-Clinical Diagnostics, Inc., for the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Test. Quantitative serology tests that are traceable to a certified reference material may be helpful 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 to SARS-CoV-2, the virus that causes COVID-19, from an individual’s blood sample (serum and plasma) to aid in identifying people with an adaptive immune response to SARS-CoV-2, indicating recent or previous SARS-CoV-2 infection.
- As part of the FDA’s effort to protect consumers, the agency issued warning letters to 12 firms for offering for sale in the U.S. adulterated and misbranded tests, face masks, respirators and surgical masks, 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 with their health care provider. The firms that received warning letters are:
- Manhattan Stitching Company, Inc.
- Professional World Store
- Mask Supply Store
- Dongguan City Xinyuan Nonwoven Co., Ltd.
- Irvin, Inc.
- Nature’s Distributing; Club Clean Inc/BuyMedicalMasksNow.com
- Zhejiang Xichen Medical Technology Co., Ltd.
- Amplicon Land, LLC
- Fixture Display LLC
- World Packaging Solutions, LLC
- On July 8, 2021, the FDA hosted a Grand Rounds lecture about regulatory science research funded by the FDA: SARS-CoV-2 Host-Pathogen Interaction, Vaccines & Variants of Concern. This lecture discussed work from two FDA Medical Countermeasures Initiative (MCMi) projects analyzing coronavirus samples to help inform development of COVID-19 medical countermeasures, conducted by Public Health England and the University of Liverpool. A webcast recording is available.
- Testing updates:
- As of today, 395 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 282 molecular tests and sample collection devices, 84 antibody and other immune response tests and 29 antigen tests. There are 52 molecular authorizations and one antibody authorization that can be used with home-collected samples. There is one molecular prescription at-home test, three antigen prescription at-home tests, five antigen over-the-counter (OTC) at-home tests and two molecular OTC at-home tests.
- The FDA has authorized 11 antigen tests and six molecular tests for serial screening programs. The FDA has also authorized 561 revisions to EUA authorizations.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
- Kim DiFonzo