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  1. Emergency Situations (Medical Devices)

Coronavirus (COVID-19) and Medical Devices

The U.S. Food and Drug Administration (FDA) is responsible for regulating medical devices used to diagnose, prevent and treat COVID-19, such as diagnostic tests, ventilators, and personal protective equipment (PPE) -- including surgical masks, face shields, respirators, gowns, and gloves.

The FDA is committed to ensuring that patients and health care providers have timely and continued access to high-quality diagnostic and therapeutic medical devices to respond effectively to the COVID-19 pandemic.


Coronavirus COVID-19 Hotline

Phone our toll-free line, 1-888-INFO-FDA, and choose option *
Hours: Monday-Friday, 8:00 a.m.-8:00 p.m. EDT, except Federal holidays.

You may also email the FDA -- See Contacts for Medical Devices During the COVID-19 Pandemic for specific email addresses.


In Vitro Diagnostic Tests: COVID-19 Tests, Including Antibody Tests

Laboratory technician wearing personal protective equipment prepares COVID-19 samples for testing

In vitro diagnostics are tests performed on samples taken from the human body, such as swabs of mucus from inside the nose or back of the throat or blood taken from a finger prick or drawn by a phlebotomist. In vitro diagnostics can detect diseases or other conditions and can be used to monitor a person's overall health to help cure, treat, or prevent diseases. Patients, as well as their physicians, depend on the FDA to ensure that the in vitro diagnostics they use to make medical decisions are accurate, reliable, and clinically meaningful.

On February 4, 2020, the Secretary of Health and Human Services (HHS) determined that there is a public health emergency and that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the novel coronavirus (2019-nCoV). Rapid detection of COVID-19 cases in the United States requires wide availability of diagnostic testing to control the emergence of this rapidly spreading, severe illness.

Personal Protective Equipment (PPE): Respirators, Surgical Masks, Gowns, Gloves, and More

Health care staff wearing PPE: masks, gloves, gowns, head coverings.

Personal protective equipment (PPE) refers to protective clothing, helmets, gloves, face shields, goggles, surgical masks, respirators, and other equipment designed to protect the wearer from injury or help prevent wearer exposure to infection or illness.

PPE is commonly used in health care settings such as hospitals, doctor's offices, and clinical labs, as well as veterinary hospitals, food production facilities, and food service settings. When used properly, PPE acts as a barrier between infectious materials (such as viral and bacterial contaminants) and your skin, mouth, nose, or eyes (mucous membranes). The barrier provided by the PPE has the potential to block transmission of contaminants from blood, body fluids, or respiratory secretions when used properly.

PPE may also protect patients who are at high risk for contracting infections through a surgical procedure or who have a medical condition, such as an immunodeficiency, from being exposed to substances or potentially infectious material brought in by visitors and health care workers.

When used properly and with other infection control practices such as hand-washing, using alcohol-based hand sanitizers, and covering coughs and sneezes, PPE minimizes the spread of infection from one person to another. Effective use of PPE includes properly removing and disposing of contaminated PPE to prevent exposing both the wearer and other people to infection.

Information about PPE and COVID-19:

The FDA recognizes that the need for PPE, such as surgical masks, surgical and isolation gowns, surgical suits, and medical gloves may outpace the supply available to health care organizations during the COVID-19 pandemic. As a result, the FDA is recommending these conservation strategies for use by health care organizations and personnel:

The FDA has issued Emergency Use Authorizations for respirators and Emergency Use Authorizations for systems that can decontaminate certain types of N95 respirators for reuse by health care personnel in a health care setting.

Ventilators

Patient in hospital bed on a ventilator

A continuous ventilator is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.

The FDA recognizes that the need for ventilators, ventilator accessories, and other respiratory devices may outpace the supply available to health care facilities during the COVID-19 pandemic. As a result, the FDA is recommending the following conservation strategies for use by health care organizations and personnel:

FDA Emergency Response Activities Related to Medical Devices

FDA COVID-19 Response At-A-Glance Summary

For the most recent information on the FDA's emergency response activities related to COVID-19, refer to the FDA's Press Announcements, including the COVID-19 (Coronavirus) Update: Daily Roundup releases.

Another excellent resource is the weekly FDA COVID-19 Response At-A-Glance Summary, which includes updates on Medical Products and Equipment as well as Guidance Document.



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