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

Coronavirus (COVID-19) and Medical Devices

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.
collage with three photos showing woman being tested for the coronavirus with a nasal swab, lab scientist wearing full personal protective gear preparing test sample with pipet, and a 3D illustration of the coronavirus

COVID-19 Diagnostic Test Accuracy and Availability

FDA has been proactive and supportive of test development to speed development and quickly authorize tests that science supports.

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.

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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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