- For Immediate Release:
The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 pandemic:
- Today, the FDA issued a warning letter to Battelle Memorial Institute for failure to comply with regulatory reporting requirements. The Battelle Memorial Institute’s Critical Care Decontamination System is authorized under an FDA Emergency Use Authorization (EUA) for decontaminating certain filtering facepiece respirators (FFRs) for reuse by health care personnel when there are insufficient supplies of FFRs due to the COVID-19 pandemic. Based on the conditions of the EUA, Battelle Memorial Institute must have Medical Device Reports (MDRs) reporting processes in place as specified in the EUA and the FDA has determined they do not. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. The FDA has an ongoing commitment to evaluate devices authorized for emergency use, to ensure compliance with conditions, and that the devices remain appropriate for authorization.
- The FDA issued a letter to health care providers recommending that health care providers give clear, step-by-step instructions to patients who, in a health care setting, are self-collecting anterior nasal samples for SARS-CoV-2 testing. Without proper instructions, patients may not collect an adequate sample for testing, which may decrease the sensitivity of the test.
- Testing updates:
- 273 tests are authorized by FDA under EUAs; these include 215 molecular tests, 53 antibody tests, and 5 antigen tests.
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.