Silver Spring, MD – The U.S. Food and Drug Administration (FDA) has announced the following actions taken in its ongoing response effort to the COVID-19 Coronavirus pandemic:
Today, the FDA published an online Consumer Update with tips on how we can each take some simple steps to help slow the spread of the coronavirus disease and protect ourselves, our families and our communities.
These steps include: Washing your hands often with soap and water; covering your mouth and nose with a non-surgical mask when around others; avoiding crowds; and practicing social distancing (e.g., staying at least six feet from others).
The FDA recently cleared for marketing in the United States a surgical gown (K200977) and three polymer patient examination gloves (K201530, K201531, K193666). These gloves and gowns are intended to be worn for medical purposes to provide a barrier against potentially infectious materials and other contaminants, including for use during the COVID-19 Coronavirus pandemic. The FDA reviewed and cleared the gown and gloves through the traditional premarket clearance (510(k)) pathway rather than through the issuance of an Emergency Use Authorization.
The FDA recently issued two Emergency Use Authorizations for molecular tests. Emergency use of the tests is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 that meet requirements to perform high complexity tests:
- LumiraDx UK Ltd., for its LumiraDx SARS-CoV-2 RNA STAR, and
- Biomeme, Inc., for its Biomeme SARS-CoV-2 Real-Time RT-PCR Test.
As part of the FDA’s effort to protect consumers, the agency issued a warning letter jointly with the Federal Trade Commission to one company for selling unapproved and misbranded COVID-19-related products. The company, Oxford Medical Instruments USA, Inc., sells salt inhaler products, including “OMI Salt Therapy Pipes,” with misleading claims that the products can mitigate, prevent, treat, diagnose, or cure COVID-19 Coronavirus in people.
There are currently no FDA-approved products to prevent or treat COVID-19 Coronavirus. FDA requested that Oxford Medical Instruments USA, Inc., immediately cease selling these unapproved and unauthorized products. Consumers concerned about COVID-19 Coronavirus should consult with their health care provider.
- To date, the FDA has currently authorized 212 tests under EUAs; these include 173 molecular tests, 37 antibody tests, and 2 antigen tests.
About the U.S. Food and Drug Administration
The U.S. Food and Drug Administration (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.