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Medical Devices

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

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

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

To Report an MDR:

Voluntary Reporting Program 1-800-FDA-1088
Mandatory Reporting Program (301) 796-6670

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

Address
Phone
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		 (301) 796-6670 (voice)
    
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