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Coronavirus (COVID-19) Update: Daily Roundup

Coronavirus (COVID-19) Update: Daily Roundup

Coronavirus (COVID-19) Update: Daily Roundup

PR Newswire

SILVER SPRING, Md., Aug. 11, 2020

SILVER SPRING, Md., Aug. 11, 2020 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) today continued to take action in the ongoing response to the COVID-19 pandemic:

  • The FDA posted a new webpage with FAQs on Importing Medical Devices During the COVID-19 Pandemic. The FDA continues critical work to protect public health during the COVID-19 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 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 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 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:

  • 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:

  • Testing updates:

Additional Resources:

Media Contact: Lee.Herring@fda.hhs.gov 
Consumer Inquiries: 888-INFO-FDA

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.

U.S. Food and Drug Administration (FDA) logo (PRNewsfoto/FDA)
U.S. Food and Drug Administration (FDA) logo (PRNewsfoto/FDA)

 

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SOURCE U.S. Food and Drug Administration