Silver Spring, MD – The U.S. Food and Drug Administration has announced the following actions taken in its ongoing response effort to the COVID-19 Coronavirus pandemic.
[1]Coronavirus
On August 4th, the FDA issued Emergency Use Authorizations (EUAs) for ventilator-related devices to:
- Lombardi Undersea, for its Subsalve Oxygen Treatment Hood [2], which is a patient interface intended for helmet-based Non-Invasive Positive Pressure Ventilation, according to clinician-established protocols to treat Acute Respiratory Distress Symptoms resulting from COVID-19 Coronavirus. The device is for use with adult patients only in Intensive Care Unit settings.
- VORTRAN Medical Technology 1, Inc., for its VORTRAN GO2VENT with PEEP Valve [3], which is intended for use by properly trained personnel to deliver emergency, short term, constant-flow pressure-cycled ventilator support with patients who weigh 10kg or more.
- Nanotronics Imaging, Inc., for its nHale [3] device, which provides bi-level positive air pressure to support respiratory therapy of spontaneously breathing adults who weigh more than 30kg and who suffer from COVID-19 Coronavirus disease in traditional healthcare facilities (e.g., hospitals, assisted living facilities, nursing homes), private homes, as well as spaces converted for the care of large numbers of COVID-19 Coronavirus patients (e.g., convention centers, university dormitories, motels).
On August 5th, the FDA issued a Surgical Masks Umbrella Emergency Use Authorization [4] in response to concerns relating to insufficient supply and availability of disposable, single-use surgical masks.
As explained in the EUA, surgical masks that meet specific performance requirements are authorized for use in health care settings by health care personnel as personal protective equipment to provide a physical barrier to fluids and particulate materials to prevent exposure to respiratory droplets and large particles during surgical mask shortages resulting from the COVID-19 Coronavirus pandemic.
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Testing updates:
To date, the FDA has currently authorized 204 tests under EUAs; these include 167 molecular tests, 35 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.