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  1. Resources for You (Medical Devices)

Consumers (Medical Devices)

Update: October 28, 2026

  • The U.S. Food and Drug Administration (FDA) has published a new consumer webpage about clear dental aligners to help patients understand the benefits, risks, and appropriate use of these prescription medical devices. You can access the webpage here.  Dental Aligners has also been added to the Consumer Topics list below.  
  • The second CDRH Patient Education Program Course Video: “Patient-Generated and Real-World Data Throughout the Medical Device Life Cycle” is now available for patients, caregivers, patient organizations, industry, and healthcare stakeholders who are interested in learning how to more effectively engage with the FDA and Medical Device Developers.  To access the YouTube video “Patient-Generated and Real-World Data Throughout the Medical Device Life Cycle,” please click here. To access both Course 1 and 2 videos click the link to the CDRH Patient Engagement Courses webpage, located under the “Resources For You” section below.

Consumer Topics

Contact Us

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

AskOICE@fda.hhs.gov

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


Sub-Topic Paragraphs

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.


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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