- 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:
- Yesterday, the FDA issued guidances for medical product developers, specifically covering vaccines, diagnostics and therapeutics products, to address the emergence and potential future emergence of variants of SARS-CoV-2, the virus that causes COVID-19
- The FDA issued a safety communication to inform patients and health care providers that pulse oximeters have limitations and a risk of inaccuracy under certain circumstances. The Pulse Oximeter Accuracy and Limitations: FDA Safety Communication provides:
- Important recommendations for patients and their caregivers on how to use pulse oximeters at home.
- Recommendations for health care providers on how to use pulse oximeters for better accuracy.
- Background on pulse oximeters and the FDA’s actions to evaluate factors that may affect pulse oximeter accuracy and performance.
- Instructions for reporting problems with pulse oximeters to the FDA.
- Testing updates:
- As of today, 331 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 247 molecular tests and sample collection devices, 70 antibody tests, and 14 antigen tests. There are 37 molecular authorizations that can be used with home-collected samples. There is one molecular prescription at-home test, one antigen prescription at-home test, and one over-the-counter (OTC) at-home antigen test.
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.