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  5. Medical Device Reporting (MDR) - Contact Information for User Facilities and Manufacturers
  1. Medical Device Reporting (MDR): How to Report Medical Device Problems

Medical Device Reporting (MDR) - Contact Information for User Facilities and Manufacturers

To Report a Significant Emergency (outside of normal East Coast business hours):

Voice (24 hr/day): (301) 796-8240 or 866-300-4374

To Report an MDR:

Voluntary Reporting Program: 1-800-FDA-1088

For information on reporting Voluntary and Mandatory Medical Device Reports, visit: Mandatory Reporting Requirements: Manufacturers, Importers and Device User Facilities.

For Questions about Medical Device Reporting, including Interpretation of policy:

Address
Food and Drug Administration
Center for Devices and Radiological Health
Reporting Systems Monitoring Branch
10903 New Hampshire Avenue
WO Bldg. 66, Rm. 3217
Silver Spring, MD 20993-0002

Email: MDRPolicy@fda.hhs.gov

Phone:
(301) 796-6670 (voice)

 
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