Where to Submit a Medical Device Report

Form 3500 VOLUNTARY MedWatch Reporting Form

Health professionals and consumers may submit reports of device adverse events or product problems to FDA via the MedWatch program in one of the following ways:

• online at: MedWatch Online Reporting Form 3500
• by telephone at 1-800-FDA-1088
• by fax at 1-800-FDA-0178
• by mail to:
  • MedWatch
    The FDA Safety Information and Adverse Event Reporting Program
    Food and Drug Administration
    5600 Fishers Lane
    Rockville, MD 20852-9787

Form 3500A MANDATORY MedWatch Reporting Form

Manufacturers, User Facilities, and Importers are required to submit certain adverse events to FDA.

Find reporting information at:

• MedWatch: The FDA Safety Information and Adverse Event Reporting Program
• Abbreviated Instructions for FDA Form 3500A Specific to Medical Device Reporting (PDF - 26KB)
• MEDWATCH Medical Device Reporting Code Instructions

Forms must be mailed to:

FDA
Center for Devices and Radiological Health
Medical Device Reporting
P. O. Box 3002
Rockville, MD 20847-3002

Alternatively, for carrier service deliveries:

FDA
Center for Devices and Radiological Health
Medical Device Reporting
16071 Industrial Drive, Room 258
Gaithersburg, Maryland 20877-1462

Form 3419 Annual User Facility Report

• Medical Device Reporting Annual User Facility Report - Form FDA3419 (PDF - 30KB)
• Instructions for Completing the Medical Device Reporting Annual User Facility Report, Form FDA3419

Contact Information for User Facilities, Importers and Manufacturers

To Report an Emergency: 

• Voice (24hr/day): (301) 443-1240
• FAX: (301) 827-3333

For Questions about Medical Device Reporting, including interpretation of MDR policy:

• Call: (301) 796-6670 (voice)
• Email: RSMB@fda.hhs.gov
• Or write to:
  • Food and Drug Administration
    Center for Devices and Radiological Health
    Reporting Systems Monitoring Branch
    10903 New Hampshire Avenue
    WO Bldg. 66, Room 3217
    Silver Spring, MD 20993-0002