U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home

Medical Devices

Topic Paragraphs
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.

Learn More

COVID-19 Updates

Image of red chat bubble with the text Medical Device Safety Communication

Do Not Use Skippack Medical Lab SARS-CoV-2 Antigen Test

May 10 – This test is not authorized, cleared, or approved by the FDA for distribution or use in the United States.

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.

Counterfeit At-Home OTC COVID-19 Diagnostic Tests

Apr 29 - These counterfeit tests should not be used or distributed.
A person using a COVID rapid test.

Use and Store At-Home COVID-19 Tests Properly

Mar 18 - FDA issued a safety communication to use and store at-home COVID-19 tests properly to avoid potential harm.

Medical Device Updates

Blue Graphic Promoting CDER's Regulatory Education for Industry (REdI)

Regulatory Education for Industry (REdI) Annual Conference

Jun 6-10 – Register for this free conference on topics including 510(k)s, inspections, and regulatory responsibilities.
Medical device recall

Philips Respironics CPAP, BiPAP, and Ventilator Recall FAQs

May 2 - Find answers to frequently asked questions on Philips Respironics ventilators, BiPAP, and CPAP machines recall.
Max-Lux Safe-T-Lite UV Wand

Max-Lux Safe-T-Lite UV WAND

The FDA issued a safety communication to warn consumers that use of the Max-Lux Safe-T-Lite UV WAND may expose the user or person nearby to unsafe levels of ultraviolet-C (UV-C) radiation and may cause injury to the skin, eyes, or both after a few seconds of use.

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.

Back to Top