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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

Coronavirus Triage Bay sign with health care worker in PPE and patient in the background

First Machine Learning-Based COVID-19 Screening Device

Tiger Tech COVID Plus Monitor identifies certain biomarkers that may be indicative of SARS-CoV-2 infection.
Girl receiving COVID nasal swab test in physician’s office

Screening Tests for COVID-19: Deciding Which Test to Use

New fact sheet for schools, workplaces, communities, and others looking to establish testing programs for COVID-19.
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

Medical folder with the words colonic polyp and a barcode

New Device Uses AI to Help Detect Signs of Colon Cancer

Apr 9 – FDA authorizes first device that uses artificial intelligence to help clinicians detect lesions during a colonoscopy.
Woman in mask meeting with physician.

Acellular Dermal Matrix (ADM) Used in Breast Reconstruction

Mar 31 - Certain ADM products used in implant-based breast reconstruction may have a higher chance for complications.
Female patient talking with health care provider both wearing masks

Chlamydia & Gonorrhea Test Allowed at Point-of-Care Settings

March 30 – FDA allows for first point-of-care chlamydia and gonorrhea test to be used in more near-patient care settings.

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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