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  1. Resources for You (Medical Devices)

The FDA is working with U.S. government partners including the Centers for Disease Control and Prevention (CDC), medical product manufacturers, and international partners to address the coronavirus disease 2019 (COVID-19) outbreak.

Answers to questions the general public and consumers may have about COVID-19, including general information and details on biologics (vaccines, human tissues and blood products), medicines, medical devices and diagnostic tests, and food can be located by viewing the webpages listed below:

 


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Medical Device Safety

Medical Device Safety Communications

The FDA monitors reports of adverse events and other problems with medical devices and alerts health professionals and the public when needed to ensure proper use of devices and the health and safety of patients.

Medical Device Recalls

FDA uses the term "recall" when a manufacturer takes a correction or removal action to address a problem with a medical device that violates FDA law. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Medical Device Safety

Consumer Updates

From simple items like tongue depressors and bedpans to complex technologies such as pacemakers, surgical implants and prosthetics, learn how FDA-regulated medical devices affect you.

How do I report a problem with a Medical Device?

MedWatch

You are encouraged to file a voluntary report by phone at 1-800-332-1088 or online at MedWatch, the FDA Safety Information and Adverse Event Reporting program if you have experienced a problem with a medical device.

FDA Consumer Complaint Coordinator

You may also wish to report adverse reactions or other problems with FDA regulated products. To do so, contact the FDA Consumer Complaint Coordinator for the state in which you reside.

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Contact Us

Contact Point
Division of Industry and Consumer Education
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Ave
Silver Spring, MD 20993

(800) 638-2041
(301) 796-7100

Hours Available

Office of Communication and Education

For Updates on Twitter follow

Contact Point Twitter

@FDADeviceInfo

Information and news on device recalls, other safety issues, approvals, and other device and radiation-emitting product topics.


Subscribe to Consumer Information for Medical Devices

Receive notifications for consumers about medical device information, recently approved devices, and alerts that may be of interest to the general public.

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