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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

Emergency Use Authorization Assessment – Final Report

COVID-19 Test EUAs: Independent Assessment of FDA’s Response

Oct 12 - The FDA released an independent assessment of the COVID-19 Emergency Use Authorization (EUA) response.
Ellume COVID-19 Home Test

Ellume COVID-19 Home Test and False Positive Results

Oct 5 – Certain lots of the Ellume COVID-19 Home Test with the potential for false positive results were recalled.
Emergency sign

Emergency Use Authorizations (EUAs) for COVID-19

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

Medical Device Updates

October is National Cybersecurity Awareness Month

Cybersecurity Awareness Month at the FDA: October 2021

Find out how the FDA helps ensure that medical devices are safe from cyber threats and how you can keep devices cybersafe.
Diagnostic Imaging hospital sign

First Major New Technology for CT Imaging in a Decade

Sep 30 - The FDA cleared Siemens NAEOTOM Alpha, a major technological improvement for Computed Tomography (CT) imaging.
Specialist analyzing images from prostate biopsies.

New Software That Can Help Identify Prostate Cancer

Sep 21 - The FDA authorized Paige Prostate, artificial intelligence (AI)-based software for analyzing biopsy images.

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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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