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:
Friday, the FDA issued an immediately in effect guidance, Enforcement Policy for Remote Digital Pathology Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency [1], to help expand the availability of devices for remote reviewing and reporting of scanned digital images of pathology slides during this public health emergency.
[2]Coronavirus
Increased availability of these devices may help to facilitate continuity of patient care by preventing disruptions to critical pathology services rendered by clinical laboratories, hospitals, and other healthcare facilities, and reduce healthcare personnel contact and risk of exposure to SARS-CoV-2.
Friday, the FDA issued [3] a Drug Safety Communication [4] regarding known side effects of hydroxychloroquine and chloroquine, including serious and potentially life-threatening heart rhythm problems, that have been reported with their use for the treatment or prevention of COVID-19 Coronavirus, for which they are not approved by the FDA.
These risks, which are in the drug labels for their approved uses, may be mitigated when health care professionals closely screen and supervise these patients such as in a hospital setting or a clinical trial, as indicated in the Emergency Use Authorization (EUA) [5] for these drugs to treat COVID-19 Coronavirus.
The FDA and Federal Trade Commission issued a warning letter to a seller of fraudulent COVID-19 Coronavirus products, as part of the agency’s effort to protect consumers. The seller warned, Prefense LLC [6], offers unapproved and misbranded hand sanitizer products for sale in the U.S. with misleading claims that the products are safe and/or effective for the prevention and treatment of COVID-19.
There are currently no FDA-approved products to prevent or treat COVID-19 Coronavirus. Consumers concerned about COVID-19 Coronavirus should consult with their health care provider.
Diagnostics update to date:
- During the COVID-19 Coronavirus pandemic, the FDA has worked with more than 380 test developers who have said they will be submitting emergency use authorizations (EUA) requests to FDA for tests that detect the virus.
- To date, the FDA has issued 44 individual emergency use authorizations [7] for test kit manufacturers and laboratories. In addition, 19 authorized tests have been added to the EUA letter of authorization for high complexity molecular-based laboratory developed tests (LDTs).
- The FDA has been notified that more than 225 laboratories have begun testing under the policies set forth in our COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance.
- The FDA also continues to keep its COVID-19 Diagnostics FAQ [8] up to date.
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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.