Contact Us

 Report Problems With Medical Devices

FDA learns about problems with medical devices through two different systems: Medical Device Reporting (MDR) and MedWatch.

Medical Device Reporting (MDR)

• Applies to manufacturers, importers, and user facilities
• Requires reporting of all significant medical device adverse events

MedWatch

• Applies to consumers and healthcare professionals
• Accepts voluntary reports of significant adverse events or problems with medical products

 Contact the Human Factors Team

To reach any member of the Human Factors Engineering Team, you can E-mail us at the address below or write to:

Human Factors Engineering Team
Center for Devices and Radiological Health
Office of Device Evaluation
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGID)
9200 Corporate Boulevard, HFZ – 480
Rockville, MD 20850

Phone: (240) 276-3823
FAX: (240) 276-3789