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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

A woman performing a nose swab on herself as part of a COVID at home test.

At-Home OTC COVID-19 Diagnostic Tests

List of authorized at-home OTC COVID-19 diagnostic tests and expiration date information.
This illustration, created at the Centers for Disease Control and Prevention (CDC), reveals ultrastructural morphology exhibited by coronaviruses. Note the spikes that adorn the outer surface of the virus, which impart the look of a corona surrounding the virion, when viewed electron microscopically. A novel coronavirus, named Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), was identified as the cause of an outbreak of respiratory illness named coronavirus disease 2019 (COVID-19).
This illustration, created at the Centers for Disease Control and Prevention (CDC), reveals the ultrastructural morphology exhibited by coronaviruses.

Medical Device Shortages

The device shortage list reflects the categories of devices the FDA has determined to be in shortage at this time.
A person using a COVID rapid test.

Use and Store At-Home COVID-19 Tests Properly

FDA issued a safety communication to use and store at-home COVID-19 tests properly to avoid potential harm.

Medical Device Updates

Microscope view of Monkey Pox

For Monkeypox Testing, Use Lesion Swab Samples to Avoid False Results

The FDA is not aware of clinical data supporting the use of other sample types, such as blood or saliva, for monkeypox testing.
Medical device recall

FAQs on Philips Respironics Ventilator, BiPAP, and CPAP Recalls

Find answers to frequently asked questions on Philips Respironics ventilators, BiPAP, and CPAP machines recall.
Images of various hearing aids

FDA Finalizes Rule to Facilitate Access to OTC Hearing Aids

This action enables consumers with perceived mild to moderate hearing impairment to purchase hearing aids from retailers without the need for a medical exam, prescription, or a fitting.

Navigate the Medical Device Section

Medical Device Safety

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

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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