Consumers (Medical Devices)

Update: July 13, 2026

The first CDRH-developed Patient Education Course is now available for patients, caregivers, patient organizations, industry, and health care stakeholders who are interested in learning how to more effectively engage with the FDA and Medical Device Developers. To access the YouTube video “Patients as Advisors in Medical Device Clinical Studies,” please click here. The video can also be found in the section below under “Resources For You.” For additional courses on patient engagement, please review the CDRH Patient Engagement webpage.

Consumer Topics

At-Home OTC COVID-19 Diagnostic Tests Automated External Defibrillators (AEDs) Baby Products with SIDS Prevention Claims Biotin Blood Glucose Monitoring Devices Cell Phones Cochlear Implants Contact Lenses Dermal Fillers (Soft Tissue Fillers)

Essure Permanent Birth Control Hearing Aids LASIK Nasal Rinsing Pulse Oximeters and Oxygen Concentrators Recalled Philips CPAP Devices Tanning Weight-Loss and Weigh-Management Devices

Popular Topics

Voluntary Recall: SoClean Equipment Used With CPAP Devices and Accessories

Breast Implants

Recalled Philips CPAP Devices

Do Not Use Smartwatches or Smart Rings to Measure Blood Glucose Levels

Home as a Health Care Hub

FDA Encourages the Public to Follow Established Choking Rescue Protocols

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.

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.

Resources for You

Adverse Event Reporting on MedWatch Learn

CDRH Patient Education Program Course Video: Patients as Advisors in Medical De…

Learn if a Medical Device has been 510(k) Cleared

Learn if a Medical Device has been Recently-Approved

What does FDA regulate?

Where to find information about Coronavirus (COVID-19) and Medical Devices

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

Office of Communication, Information Disclosure, Training and Education

For Latest Updates Follow

@FDADeviceInfo

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