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 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.
- Read frequently asked questions about:
- Read the FDA Fact sheet - Antibody Test Oversight and Use for Covid-19
- See the list of diagnostic tests available through Emergency Use Authorizations
- EUA Authorized Serology Test Performance
- Important Information on the Use of Serological (Antibody) Tests for COVID-19 - Letter to Health Care Providers
- Transport Media Safety Risk - Use Compatible Transport Media with SARS-CoV-2 Tests that Use Bleach - Letter to Clinical Laboratory Staff and Health Care Providers
- Certain COVID-19 Serology/Antibody Tests Should Not Be Used - Letter to Clinical Laboratory Staff and Health Care Providers
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:
- Questions about Personal Protective Equipment
- Frequently Asked Questions on Shortages of Surgical Masks and Gowns
- Frequently Asked Questions on 3D Printing of Medical Devices, Accessories, Components, and Parts During the COVID-19 Pandemic
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:
- Medical Glove Conservation Strategies - Letter to Health Care Providers
- Surgical Mask and Gown Conservation Strategies - Letter to Health Care Providers
- Certain Filtering Facepiece Respirators from China May Not Provide Adequate Respiratory Protection - Letter to Health Care Providers
- Risk of Misinterpreting Hydrogen Peroxide Indicator Colors for Vapor Sterilization - Letter to Health Care Providers
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.
- See the list of Emergency Use Authorizations (EUAs) related to personal protective equipment.
- Use the Correct Cycle and Compatible N95 Respirators When Decontaminating Respirators with STERRAD Sterilization Systems - Letter to Health Care Providers
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:
- Ventilator Supply Mitigation Strategies - Letter to Health Care Providers
- See the Emergency Use Authorization related to ventilators, anesthesia gas machines modified for use as ventilators, and positive pressure breathing devices modified for use as ventilators
- Read Frequently Asked Questions on Ventilators
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.
In response to the COVID-19 pandemic, the FDA has issued Emergency Use Authorizations (EUA) for various diagnostic, therapeutic, and protective medical devices to respond to COVID-19.
- Blood Purification Devices
- Continuous Renal Replacement Therapy and Hemodialysis Devices
- Decontamination Systems for Personal Protective Equipment
- In Vitro Diagnostics
- Infusion Pump
- Personal Protective Equipment
- Remote and Wearable Patient Monitoring Devices
- Respiratory Assist Devices
- Ventilators and Ventilator Accessories
- Other Medical Devices
The FDA has the authority to issue EUAs for certain products to diagnose, treat, or prevent COVID-19 when specific criteria are met.
Guidance documents are documents issued by the FDA that describe the agency's interpretation of or policy on a regulatory issue. The title of the guidance often indicates the intended audiences for the guidance, such as industry (medical device manufacturers and distributors), clinical laboratories, and FDA staff.
To address the COVID-19 public health emergency, the FDA has determined that prior public participation for the following guidance documents is not feasible or appropriate. Accordingly, the FDA issued these guidances without prior public comment.
These guidance documents are immediately in effect, but they remain subject to public comment in accordance with the FDA's good guidance practices.
The FDA regularly issues and updates answers to frequently asked questions (FAQs) related to specific medical devices and the COVID-19 pandemic.