FDA takes action to help increase U.S. supply of ventilators and respirators for protection of health care workers, patients

Statement from Stephen M. Hahn M.D. , Commissioner of Food and Drugs – Food and Drug Administration

The U.S. Food and Drug Administration took action to help increase the supply of ventilators, ventilator tubing connectors, and ventilator accessories, as well as filtering facepiece respirators (FFRs) due to shortages during COVID-19, as part of our commitment to ease burdens on the health care system during this pandemic.

The FDA issued an Emergency Use Authorization (EUA) to allow for the emergency use in health care settings of certain ventilators, anesthesia gas machines modified for use as ventilators, and positive pressure breathing devices modified for use as ventilators (collectively referred to as “ventilators”), ventilator tubing connectors, and ventilator accessories that the FDA determines meet specified criteria for safety, performance and labeling.

Ventilator tubing connectors are used for multiplexing certain continuous ventilators intended for use in a health care facility, which means one ventilator may be used for multiple patients simultaneously. The devices that are eligible for inclusion under this EUA are those that are not currently marketed in the U.S., or that are currently marketed in the U.S. but a modification is made to the device that would trigger the requirement that a manufacturer submit a new premarket notification (510(k)) to the FDA, as discussed in the agency’s Ventilator Enforcement Policy.

This EUA demonstrates our ability to react and adapt quickly during this pandemic by providing maximum regulatory flexibility and helping to increase the U.S. ventilator inventory so that very ill patients have access to lifesaving devices they need, while still providing appropriate FDA oversight.

The FDA also issued an EUA for certain imported non-NIOSH-approved respirators that have been designed, evaluated and validated to meet a performance standard specified in the EUA and/or that have a marketing authorization in certain specified jurisdictions, subject to the conditions of authorization. Respirators that are authorized under the EUA are authorized for use in health care settings by health care personnel in accordance with recommendations from the Centers for Disease Control and Prevention to prevent exposure to airborne particulates.

This new EUA covering certain respirators does not affect the previous March 2, 2020 EUA, which authorizes, in part, the emergency use of certain respirators approved by NIOSH, for use in health care settings by health care providers.

For the most current CDC recommendations on optimizing respirator use, please visit CDC’s webpage: Strategies for Optimizing the Supply of N95 Respirators. This EUA does not permit use of authorized respirators by the general public.

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.

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