U.S. flag An official website of the United States government
  1. Home
  2. Emergency Preparedness and Response
  3. Counterterrorism and Emerging Threats
  4. Coronavirus Disease 2019 (COVID-19)
  1. Counterterrorism and Emerging Threats

Coronavirus Disease 2019 (COVID-19)

FDA is working with U.S. Government partners, including CDC, and international partners to address the coronavirus disease 2019 (COVID-19) outbreak.

For information on how to protect yourself and what to do if you think you are sick, visit www.coronavirus.gov.

image of man sneezing and graphic representation of a coronavirus
FDA is working with U.S. Government partners, including CDC, and international partners to address the coronavirus disease 2019 (COVID-19) outbreak.

 


Latest COVID-19 Information From the FDA

Date Update Type Product Area
04/01/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA actions on the FDA-ARGOS SARS-CoV-2 Reference Grade Sequence Data, temporary flexibility to chain restaurants and similar retail food establishments, warning letters, and more in its ongoing response to the COVID-19 pandemic

Daily Roundup  
03/31/2020

FDA: Food Access and COVID-19

Food availability and food safety are vitally important to our well-being, and the FDA is working hard to help ensure the foods you, your family, and your pets eat are safe and available during the COVID-19 pandemic.

Video Length: 1:20

Safety Information Food & Beverages
03/31/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA actions on the Coronavirus Treatment Acceleration Program, shortages of hydroxychloroquine and chloroquine, warning letters, and more in its ongoing response to the COVID-19 pandemic.

Daily Roundup  
03/31/2020

Coronavirus (COVID-19) Update: FDA Continues to Accelerate Development of Novel Therapies for COVID-19

The FDA stood up a new program to expedite the development of potentially safe and effective life-saving treatments. The program, known as the Coronavirus Treatment Acceleration Program (CTAP), is using every tool at the agency’s disposal to bring new therapies to sick patients as quickly as possible, while at the same time supporting research to further evaluate whether these medical countermeasures are safe and effective for treating patients infected with this novel virus.

Press Release / Public Statement Drugs
Biologics
03/30/2020

Coronavirus (COVID-19) Update: Daily Roundup

FDA actions on hydroxychloroquine sulfate and chloroquine phosphate products, N95 respirators, surgical apparel for health care professionals, and more in its ongoing response to the COVID-19 pandemic.

Daily Roundup  
03/30/2020

Virtual Town Hall Series – Topic: Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests

On April 1, 2020, the FDA will host the first of a series of virtual Town Halls for clinical laboratories and commercial manufacturers that are developing or have developed diagnostic tests for SARS-CoV-2.

Event Medical Devices
03/30/2020

Coronavirus (COVID-19) Update: FDA expedites review of diagnostic tests to combat COVID-19

The FDA has been providing unprecedented flexibility to labs and manufacturers to develop and offer COVID-19 tests across the U.S. Every action the FDA has taken during this public health emergency to address the COVID-19 pandemic has balanced the urgent need to make diagnostic tests available with providing a level of oversight that ensures accurate tests are being deployed.

Press Release / Public Statement Medical Devices
03/30/2020

FDA on Signing of the COVID-19 Emergency Relief Bill, Including Landmark Over-the-Counter Drug Reform and User Fee Legislation

The law grants the FDA transformative, new authorities that will meaningfully advance our efforts to modernize the OTC drug development and review process to help advance innovative, safe and effective options for consumers and secure a robust OTC marketplace.

Press Release / Public Statement Drugs
03/28/2020

Coronavirus (COVID-19) Update: FDA takes further steps to help mitigate supply interruptions of food and medical products

The FDA is continuously examining the global supply chain to identify any concerns and assess the availability of the products Americans need most. We are also partnering with the Federal Emergency Management Agency (FEMA) on supply chain issues, including importation of needed medical products to support the U.S. response.

Press Release / Public Statement

Medical Devices

Drugs

Biologics

Animal & Veterinary

Food & Beverages

03/27/2020

Coronavirus (COVID-19) Update: Daily Roundup

Actions by the FDA in our ongoing response to the COVID-19 pandemic

Daily Roundup  
03/27/2020

Food Safety and Availability During the Coronavirus Pandemic

There is no evidence of food or food packaging being associated with transmission of the coronavirus. Currently there are no food shortages nationwide, although certain foods may be temporarily out of stock.

Safety Information Food & Beverages
03/27/2020

Coronavirus (COVID-19) Update: FDA takes action to help increase U.S. supply of ventilators and respirators for protection of health care workers, patients

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.

Press Release / Public Statement Medical Devices
03/27/2020

Safely Using Hand Sanitizer

You can help stop the spread of COVID-19 by washing your hands with soap and water; if soap and water are not available, alcohol-based hand sanitizers can be used if they contain at least 60% alcohol and are used properly.

Safety Information  Drugs
03/26/2020

Coronavirus (COVID-19) Update: Daily Roundup

Actions by the FDA in our ongoing response to the COVID-19 pandemic.

Daily Roundup  
03/25/2020

FDA, Department of Veterans Affairs, National Institutes of Health, and America Makes Form a COVID-19 Response Public-Private Partnership

The FDA entered a Memorandum of Understanding (MOU) with the VA Innovation Ecosystem and the NIH 3D Print Exchange, to share data and coordinate on open-source medical products for the COVID-19 response. These agencies are also working closely with America Makes to provide resources that will connect health care providers and 3D printing organizations. 

Safety Information Medical Devices
03/25/2020

Coronavirus (COVID-19) Update: Daily Roundup

Actions by the FDA in our ongoing response to the COVID-19 pandemic.

Daily Roundup  
03/24/2020

Coronavirus (COVID-19) Update: Daily Roundup

Actions by the FDA in our ongoing response to the COVID-19 pandemic.

Daily Roundup  
03/24/2020

Beware of Fraudulent Coronavirus Tests, Vaccines and Treatments

There are currently no FDA-approved drugs, including vaccines, to treat or prevent COVID-19.

Safety Information

Medical Devices

Drugs

Biologics

03/24/2020

FDA Offers Assurance About Food Safety and Supply for People and Animals During COVID-19

The U.S. food supply remains safe for both people and animals during the COVID-19 pandemic.

FDA Voices Post Animal & Veterinary, Food & Beverages
03/24/2020

Coronavirus (COVID-19) Update: FDA takes action to increase U.S. supplies through instructions for PPE and device manufacturers

The FDA took action to increase U.S. supplies to support the U.S. response to COVID-19 by providing instructions to manufacturers importing personal protective equipment and other devices.

Press Release / Public Statement  
03/24/2020

Investigational COVID-19 Convalescent Plasma - Emergency INDs

Information for healthcare providers about convalescent plasma—plasma collected from the blood of fully recovered COVID-19 patients and given as treatment to very ill COVID-19 patients.

Safety Information Biologics
03/24/2020

Coronavirus (COVID-19) Update: FDA Helps Facilitate Veterinary Telemedicine During Pandemic

The FDA announced today that it intends to temporarily not enforce certain requirements in order to allow veterinarians to better utilize telemedicine to address animal health needs during the pandemic.

Press Release / Public Statement Animal & Veterinary
03/23/2020

Coronavirus (COVID-19) Update: Daily Roundup

Actions by the FDA in our ongoing response to the COVID-19 pandemic.

Daily Roundup  
03/23/2020

FDA and EMA Collaborate to Facilitate SARS-CoV-2 Vaccine Development

FDA and the European Medicines Agency jointly chaired the first global regulators meeting to discuss ways to streamline the development of SARS-CoV-2 vaccines.

FDA Voices Post Biologics
03/22/2020

Coronavirus (COVID-19) Update: FDA provides update on patient access to certain REMS drugs during COVID-19 public health emergency

The FDA issued a new guidance to sponsors and healthcare providers regarding certain Risk Evaluation and Mitigation Strategy (REMS)-required testing during this time.

Press Release / Public Statement Drugs
03/22/2020

Coronavirus (COVID-19) Update: FDA Continues to Facilitate Access to Crucial Medical Products, Including Ventilators

The FDA took significant action to help increase the availability of ventilators and accessories, as well as other respiratory devices, during the COVID-19 pandemic to support patients with respiratory failure or difficulty breathing.

Press Release / Public Statement Medical Devices
03/21/2020

Coronavirus (COVID-19) Update: FDA Issues first Emergency Use Authorization for Point of Care Diagnostic

The FDA issued the first emergency use authorization for a point-of-care COVID-19 diagnostic for the Cepheid Xpert Xpress SARS-CoV-2 test.

Press Release / Public Statement Medical Devices
03/20/2020

Coronavirus (COVID-19) Update: FDA Alerts Consumers About Unauthorized Fraudulent COVID-19 Test Kits

The FDA is actively and aggressively monitoring the market for any firms marketing products with fraudulent coronavirus (COVID-19) diagnostic, prevention and treatment claims as part of our ongoing efforts to protect public health during this pandemic. As a result of these activities, the agency is beginning to see unauthorized fraudulent test kits that are being marketed to test for COVID-19 in the home.

Press Release / Public Statement Medical Devices
03/20/2020

Preguntas más frecuentes acerca de la Enfermedad del Coronavirus 2019 (COVID-19)

Coronavirus Disease 2019 (COVID-19) Frequently Asked Questions are now available in Spanish.

Safety Information  
03/20/2020

Coronavirus (COVID-19) Update: FDA allows expanded use of devices to monitor patients’ vital signs remotely

The FDA issued a new policy that allows manufacturers of certain FDA-cleared non-invasive, vital sign-measuring devices to expand their use so that health care providers can use them to monitor patients remotely. The devices include those that measure body temperature, respiratory rate, heart rate and blood pressure.

Press Release / Public Statement Medical Devices
03/20/2020

Coronavirus (COVID-19) Update: FDA provides guidance on production of alcohol-based hand sanitizer to help boost supply, protect public health

As part of the U.S. Food and Drug Administration’s ongoing commitment to address the coronavirus (COVID-19) pandemic, the agency has issued two guidance documents to communicate its policy for the temporary manufacture of certain alcohol-based hand sanitizer products. These guidance documents will be in effect for the duration of the public health emergency declared by the Secretary of Health and Human Services (HHS) on January 31, 2020.

Press Release / Public Statement Drugs
03/19/2020

DHS Issues Guidance on the Essential Critical Infrastructure Workforce

The Department of Homeland Security (DHS)/Cybersecurity & Infrastructure Agency (CISA) issued new guidance to support state, local, and industry partners in identifying the critical infrastructure sectors and the essential workers needed to maintain the services and functions Americans depend on daily and need to be able to operate resiliently during the COVID-19 pandemic response. This includes essential workers in the food, health care, and public health sectors, including FDA-regulated industries.

   
03/19/2020

FDA advises patients on use of non-steroidal anti-inflammatory drugs (NSAIDs) for COVID-19

At this time, FDA is not aware of scientific evidence connecting the use of NSAIDs, like ibuprofen, with worsening COVID-19 symptoms. The agency is investigating this issue further and will communicate publicly when more information is available.

Safety Information Drugs
03/19/2020

Coronavirus (COVID-19) Update: FDA Continues to Facilitate Development of Treatments

The U.S. Food and Drug Administration continues to play a critical role in the multifaceted all-of-government response to the COVID-19 pandemic, which includes, among other things, facilitating medical countermeasures to treat and prevent the disease, and surveilling the medical product and food supply chains for potential shortages or disruptions and helping to mitigate such impacts, as necessary.

Press Release / Public Statement Biologics, Drugs
03/19/2020

Coronavirus (COVID-19) Update: Blood Donations

The nation’s blood supply requires a steady supply of donors who generously donate millions of units of potentially life-saving blood and blood components each year. At this time the number of blood donations has been dramatically reduced due to the implementation of social distancing and the cancellation of blood drives. In order to ensure that blood is available to those who need it most, it is important for healthy individuals who are able to donate to take the time to do so.

Press Release / Public Statement Biologics
03/18/2020

Coronavirus (COVID-19) Update: FDA Focuses on Safety of Regulated Products While Scaling Back Domestic Inspections

For the health and well-being of our staff and those who conduct inspections for the agency under contract at the state level, and because of industry concerns about visitors, we have temporarily postponed all domestic routine surveillance facility inspections. These are facility inspections the FDA traditionally conducts every few years based on a risk analysis. Importantly, all domestic for-cause inspection assignments will be evaluated and will proceed if mission-critical.

Press Release / Public Statement  
03/18/2020

Coronavirus (COVID-19) Update: FDA issues a guidance on conducting clinical trials

The FDA took steps to help industry and investigators navigate the COVID-19 pandemic and move forward with conducting clinical trials.

Press Release / Public Statement  
03/18/2020

FDA Briefing for Foods Stakeholders on Coronavirus Disease 2019 (COVID-19)

The FDA hosted a stakeholder call to discuss food safety and food supply questions, respond to concerns, and highlight key FDA resources for the response to the COVID-19 pandemic.

Event Food & Beverages
03/17/2020

Coronavirus (COVID-19) Update: FDA Issues Temporary Policy for FSMA Onsite Audit Requirements

The FDA took steps to help prevent disruptions in the food supply-chain by issuing a temporary policy for FDA Food Safety Modernization Act (FSMA) supplier verification onsite audit requirements during the coronavirus (COVID-19) public health emergency.

Press Release / Public Statement Food & Beverages
03/16/2020

Coronavirus (COVID-19) Update: FDA Issues Diagnostic Emergency Use Authorization to Hologic and LabCorp

The FDA took two additional significant diagnostic actions during the coronavirus outbreak (COVID-19) by issuing Emergency Use Authorizations (EUAs) to: Hologic for its Panther Fusion SARS-COV-2 Assay, and Laboratory Corporation of America (LabCorp) for its COVID-19 RT-PCR test.

Press Release / Public Statement Medical Devices
03/16/2020

Coronavirus (COVID-19) Update: FDA Provides More Regulatory Relief During Outbreak, Continues to Help Expedite Availability of Diagnostics

The FDA updated a policy originally issued on Feb. 29 on diagnostic testing for coronavirus (COVID-19) in order to achieve more rapid testing capacity in the U.S.

Press Release / Public Statement Medical Devices
03/13/2020

Coronavirus (COVID-19) Update: FDA Issues Emergency Use Authorization to Thermo Fisher

The FDA took another significant diagnostic action during the coronavirus outbreak (COVID-19). The FDA issued the fourth COVID-19 diagnostic Emergency Use Authorization (EUA) to Thermo Fisher for its TaqPath COVID-19 Combo Kit.

Press Release / Public Statement Medical Devices
03/12/2020

Coronavirus (COVID-19) Update: FDA gives flexibility to New York State Department of Health, FDA issues Emergency Use Authorization diagnostic

The two significant actions will expedite the availability of diagnostic tests.

Press Release / Public Statement Medical Devices
03/10/2020

Coronavirus Disease 2019 (COVID-19) Update: Foreign Inspections

After careful consideration, the FDA is postponing most foreign inspections through April, effective immediately. Inspections outside the U.S. deemed mission-critical will still be considered on a case-by-case basis.

Press Release / Public Statement  
03/09/2020

Coronavirus Update: FDA and FTC Warn Seven Companies Selling Fraudulent Products that Claim to Treat or Prevent COVID-19

The FDA and the Federal Trade Commission issued warning letters to seven companies for selling fraudulent COVID-19 products.  These products are unapproved drugs that pose significant risks to patient health and violate federal law.  The FDA and FTC are taking this action as part of their response in protecting Americans during the global COVID-19 outbreak.

Press Release / Public Statement Dietary Supplements, Drugs, Food & Beverages
03/07/2020

Coronavirus (COVID-19) Update: White House Press Briefing by FDA Commissioner Stephen M. Hahn, M.D.

Event  
03/06/2020

Virtual Town Hall - Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency

The FDA hosted a town hall for laboratories certified to perform high-complexity testing under the Clinical Laboratory Improvement Amendments (CLIA) that are developing or have developed molecular diagnostic tests for SARS-CoV-2.

Event  
03/04/2020

Remarks by FDA Commissioner Stephen Hahn to the American Clinical Laboratory Association

The Commissioner's remarks highlighted the role of diagnostic testing in the COVID-19 response.

Event  
03/03/2020

HHS officials testified at a Senate HELP Hearing, An Emerging Disease Threat: How the U.S. Is Responding to COVID-19, the Novel Coronavirus.

  • Remarks by Dr. Anne Schuchat, Principal Deputy Director, Centers for Disease Control and Prevention; Dr. Anthony Fauci, Director, National Institute of Allergy and Infectious Diseases, National Institutes of Health; Dr. Robert Kadlec, Assistant Secretary for Preparedness and Response, U.S. Department of Health and Human Services; and Dr. Stephen Hahn, Commissioner, U.S. Food and Drug Administration
Event  
03/02/2020

Webinar: Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests

The FDA hosted a webinar for laboratories certified to perform high-complexity testing under the Clinical Laboratory Improvement Amendments (CLIA), and others interested in learning more about this guidance.

Event Medical Devices
03/02/2020

Coronavirus (COVID-19) Update: FDA and CDC take action to increase access to respirators, including N95s, for health care personnel

In a joint effort, the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention took action to make more respirators, including certain N95s, available to health care personnel. Currently, the majority of respirators on the market are indicated for use in industrial settings. Today’s action allows certain National Institute for Occupational Safety and Health (NIOSH) approved respirators not currently regulated by the FDA to be used in a health care setting by health care personnel during the coronavirus (COVID-19) outbreak, thereby maximizing the number of respirators available to meet the needs of the U.S. health care system.

Press Release / Public Statement Medical Devices
02/29/2020

Coronavirus (COVID-19) Update: FDA Issues New Policy to Help Expedite Availability of Diagnostics

As part of the U.S. Food and Drug Administration’s ongoing and aggressive commitment to address the coronavirus outbreak, the agency issued a new policy for certain laboratories seeking to develop diagnostic tests for coronavirus in order to achieve more rapid testing capacity in the U.S.

Press Release / Public Statement Medical Devices
02/27/2020

Coronavirus (COVID-19) Supply Chain Update

FDA has been closely monitoring the supply chain with the expectation that the COVID-19 outbreak would likely impact the medical product supply chain, including potential disruptions to supply or shortages of critical medical products in the U.S. A manufacturer has alerted us to a shortage of a human drug that was recently added to the drug shortages list. The manufacturer just notified us that this shortage is related to a site affected by coronavirus. The shortage is due to an issue with manufacturing an active pharmaceutical ingredient used in the drug. It is important to note that there are other alternatives that can be used by patients. We are working with the manufacturer as well as other manufacturers to mitigate the shortage. We will do everything possible to mitigate the shortage.

Press Release / Public Statement Animal & Veterinary, Biologics, Drugs, Food & Beverages, Medical Devices
02/24/2020

Coronavirus Update: FDA steps to ensure quality of foreign products

FDA continues to take a multi-pronged approach to this public health emergency, including focusing on actively facilitating efforts to diagnose, treat and prevent the disease; surveilling the medical product supply chain for potential shortages or disruptions and helping to mitigate such impacts, as necessary; and leveraging the full breadth of our public health tools, including enforcement tools to stop fraudulent activity.

Press Release / Public Statement  
02/14/2020

FDA’s Actions in Response to 2019 Novel Coronavirus at Home and Abroad

FDA is an active partner in the Novel Coronavirus (COVID-19) response, working closely with our government and public health partners across the U.S. Department of Health and Human Services, as well as with our international counterparts. Our work is multifaceted, focusing on actively facilitating efforts to diagnose, treat and prevent the disease; surveilling the medical product supply chain for potential shortages or disruptions and helping to mitigate such impacts, as necessary; and leveraging the full breadth of our public health tools as we oversee the safety and quality of FDA-regulated products for American patients and consumers.

Press Release / Public Statement  
02/11/2020

The World Health Organization announced an official name for the disease that is causing the current outbreak of coronavirus disease, COVID-19. FDA's website has been updated to reflect the updated name.

Press Release / Public Statement  
02/05/2020

CDC Media Telebriefing: Update on 2019 Novel Coronavirus (COVID-19), including updates from FDA Chief Scientist RADM Denise Hinton.

Press Release / Public Statement  
02/04/2020

FDA Takes Significant Step in Coronavirus Response Efforts, Issues Emergency Use Authorization (EUA) for the First 2019 Novel Coronavirus Diagnostic

FDA issued an EUA to enable broader emergency use of the Centers for Disease Control and Prevention’s (CDC) 2019-nCoV Real-Time RT-PCR Diagnostic Panel. To date, this test has been limited to use at CDC laboratories; today’s authorization allows the use of the test at any CDC-qualified lab across the country.

Press Release / Public Statement Medical Devices
01/30/2020

The HHS Assistant Secretary for Preparedness and Response (ASPR) hosted a stakeholder listening session (transcript PDF) to discuss medical countermeasure challenges associated with 2019-nCoV outbreak. FDA Acting Assistant Commissioner for Counterterrorism Policy Michael Mair provided FDA remarks.

Press Release / Public Statement Medical Devices
01/27/2020

FDA Announces Key Actions to Advance Development of Novel Coronavirus Medical Countermeasures

“We have a vital mission to protect and promote public health and the FDA is closely collaborating with our domestic and international public health partners to mitigate the impact of the novel coronavirus that emerged in Wuhan, China,” said FDA Commissioner Stephen M. Hahn, M.D. “We are actively leveraging the vast breadth of the FDA’s expertise and have begun employing the full range of our public health authorities to facilitate the development and availability of investigational medical products to help address this urgent public health situation.”

Press Release / Public Statement Medical Devices

For updates on Twitter, follow:
@SteveFDA, @US_FDA, @FDA_Global and @FDA_MCMi.


Information From the Federal Government

Information curated by the Coronavirus (COVID-19) Task Force at the White House.


Public health and safety information and for the overarching medical and health provider community.


A catalog of U.S. government activities related to COVID-19.

back to top


Frequently Asked Questions

Woman looking at computer with man in the background

Answers to questions the general public and consumers may have about COVID-19, including general information and details on biologics (vaccines, human tissues and blood products), medicines, medical devices and diagnostic tests, and food. 

back to top


Medical Countermeasures

There are currently no FDA-approved medical countermeasures for COVID-19. FDA stands ready to work with medical product developers to clarify regulatory and data requirements necessary to move products forward in development as quickly as possible.


How to Help 

  • If you have medical supplies or equipment to donate, please provide the Federal Emergency Management Agency (FEMA) details on what you are offering through the FEMA online medical supplies and equipment form.
  • To sell medical supplies or equipment to the federal government, please submit a price quote under the COVID-19 PPE and Medical Supplies Request for Quotation
  • If you are a private company that wants to produce a product related to the COVID response – email nbeoc@max.gov.
  • For additional information on how to help, visit FEMA’s How to Help webpage
  • If you are a hospital or healthcare provider in need of medical supplies, please contact your state, local, tribal or territory department of public health and/or emergency management agency.

 

back to top


Health Fraud

  • Fraudulent Coronavirus Disease 2019 (COVID-19) Products - The FDA is actively monitoring for any firms marketing products with fraudulent COVID-19 prevention and treatment claims. The FDA is exercising its authority to protect consumers from firms selling unapproved products and making false or misleading claims, including, by pursuing warning letters, seizures, or injunctions against products and firms or individuals that violate the law.

back to top


 

Contact FDA

Consumers and General Information

Press Inquiries

Report a Problem

Sponsors and Developers

back to top


Additional Resources



Subscribe

Sign up to receive email alerts on emergency preparedness and response topics from FDA, including medical countermeasures, COVID-19, and other emerging infectious diseases.