Silver Spring, MD – The U.S. Food and Drug Administration (FDA) has taken the following actions in its ongoing response effort to the COVID-19 Coronavirus pandemic:
The FDA posted a new webpage with FAQs on Importing Medical Devices During the COVID-19 Coronavirus Pandemic.
The FDA continues critical work to protect public health during the COVID-19 Coronavirus pandemic, including reviewing shipments of medical devices offered for import.
The FAQ webpage provides information on importing devices that have been issued Emergency Use Authorizations (EUAs) and devices for which an enforcement-discretion policy has been published in a guidance document.
The webpage includes content on importing respirators, face masks, and personal protective equipment (PPE), donating medical devices, importing other medical devices, monitoring import status, and identifying contacts for import questions.
Today, the FDA posted a new webpage with FAQs on Registration and Listing of Medical Devices During the COVID-19 Coronavirus Pandemic. This webpage provides information for medical device establishments, including owners and operators of places of business (also called facilities) that are involved in the production (e.g., manufacturing, assembling, processing) and distribution of medical devices that are authorized by Emergency Use Authorizations (EUAs) or that are the subject of one of FDA’s COVID-19 Coronavirus guidance documents.
In general, most facilities required to register with FDA are also required to list the devices they manufacture, prepare, propagate, compound, assemble, or process and the activities they perform on such devices. This webpage answers frequently asked questions about procedures and requirements concerning the registration of facilities and the listing of devices during the COVID-19 Coronavirus pandemic.
A U.S. District Court in Florida has granted motions for default judgment and entered permanent injunctions against defendants Genesis III Church of Health and Healing, Mark Grenon, Joseph Grenon, Jonathan Grenon, and Jordan Grenon for violating federal law by distributing their product, “Miracle Mineral Solution,” an industrial bleach that the defendants claimed is a cure for COVID-19 and other serious diseases.
The orders prohibit the defendants from selling or distributing unapproved or misbranded products such as Mineral Miracle Solution (MMS). Related to this action:
- The FDA continues to advise consumers to stop using the MMS product immediately and dispose of it. In addition, consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program.
- In prior warning statements, the FDA has urged consumers not to purchase or use MMS, explaining that drinking MMS is the same as drinking bleach and can cause dangerous side effects, including severe vomiting, diarrhea, and life-threatening low-blood pressure.
As part its continued efforts to protect the American public, the FDA issued a warning letter to Soluciones Cosmeticas, SA de CV, for Bersih hand sanitizers that are labeled to contain ethanol (also known as ethyl alcohol) but tested positive for methanol contamination.
Methanol is not an acceptable ingredient for hand sanitizer products and can be toxic when absorbed through the skin as well as life-threatening when ingested. FDA urges consumers not to use any products on the agency’s list of hand sanitizers with potential methanol contamination or subpotent levels of ethanol or isopropyl alcohol, and continue checking this list often, as it is being updated frequently.
FDA has issued Emergency Use Authorizations to the following companies for their respective tests:
- Solaris Diagnostics, for its molecular Solaris Multiplex SARS-CoV-2 Assay, and
- Alpha Genomix Laboratories, for its molecular Alpha Genomix TaqPath SARS-CoV-2 Combo Assay.
To date, the FDA has currently authorized 210 tests under EUAs; these include 171 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.