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Images of FDA-regulated medical devices: infrared thermometer, mask, gloves diagnostic test, ventilator

Medical Devices and the COVID-19 (Coronavirus) Pandemic

Learn more about devices such as diagnostic tests, ventilators, and personal protective equipment (PPE)—including surgical masks, face shields, respirators, gowns, and gloves.

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COVID-19 Updates

picture of antibodies from serology test

Serological (Antibody) Tests for COVID-19: Revised Policy

FDA outlines expectations for antibody test manufacturers, creates streamlined processes for independent validation.
Emergency sign

Emergency Use Authorizations (EUAs) for COVID-19

EUAs make available diagnostic tests, respirators, ventilators, and related devices for COVID-19.
ask questions faq

Get Answers to Your Questions about Specific Devices

See FAQS Related to COVID-19 for info about diagnostic tests, PPE, EUAs, 3D printing, and their use during the pandemic.

COVID-19 Info for Health Care Providers

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

Surgical Gowns and Masks: Conservation Strategies

Recommended conservation strategies for surgical masks, surgical and isolation gowns, and surgical suits (scrubs).
medical glove

Medical Glove Conservation Strategies

Recommended conservation strategies for surgeon’s gloves and patient examination gloves.
Patient in hospital bed on a ventilator

Ventilator Supply Mitigation Strategies

Recommendations for the use of ventilators, ventilator accessories, and other respiratory devices.

Navigate the Medical Device Section

Medical Device Safety

Safety Communications, Recalls, Letters to Health Care Providers, Reporting Adverse Events (MDR and MedSun)

Digital Health

Cybersecurity, mobile medical applications, wireless medical devices, Software as Medical Device (SaMD)

Science and Research

CDRH research programs, epidemiology, medical device development tools (MDDT)

International Programs

International Medical Device Regulators Forum, Medical Device Single Audit Program (MDSAP)

News & Events

CDRHNew daily updates, webinars, meetings, workshops, conferences

Resources for You

Information for consumers and health care providers, letters to industry

Search Medical Device Databases

more: Search Medical Device Databases

How Do I

Find Guidance Documents

Get Information on CDRH

Contact Us

Division of Industry and Consumer Education
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Ave
Silver Spring, MD 20993

DICE@fda.hhs.gov

(800) 638-2041
(301) 796-7100

Hours Available

Office of Communication and Education

@FDADeviceInfo

Information and news on device recalls, other safety issues, approvals, and other device and radiation-emitting product topics.

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