- 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:
- On August 25, the FDA issued a Letter to Health Care Providers alerting health care facility risk managers, procurement staff and health care personnel to stop using certain N95 respirators manufactured by Shanghai Dasheng Health Products Manufacture Co., Ltd. (Shanghai Dasheng).
The Centers for Disease Control and Prevention’s National Institute for Occupational Safety and Health (NIOSH) revoked all respirator approvals previously issued to Shanghai Dasheng because the firm did not implement, maintain and control a quality management system. All previously authorized Shanghai Dasheng respirators are no longer authorized for emergency use as a result of the loss of NIOSH-approval.
- As part of the FDA's effort to protect consumers from products making unproven claims about mitigating, preventing, treating, diagnosing or curing COVID-19 in people, on August 24, the agency issued a warning letter to Invisi Smart Technologies for offering for sale adulterated and misbranded Invisi Smart Masks. Consumers concerned about COVID-19 should consult with their health care provider.
- Testing updates:
- As of today, 407 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 285 molecular tests and sample collection devices, 88 antibody and other immune response tests and 34 antigen tests. There are 60 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, seven antigen over-the-counter (OTC) at-home tests and two molecular OTC at-home tests.
- The FDA has authorized 14 antigen tests and eight molecular tests for serial screening programs. The FDA has also authorized 613 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.
- Jim McKinney