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Medical Device Reporting (MDR) - Contact Information for User Facilities and Manufacturers |
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For Emergencies
Questions
Reporting an MDR by Telephone
To report a signifcant emergency (outside of normal East Coast business hours):
| FAX | (301) 827-3333 |
| Voice (24 hr/day) | (301) 443-1240 |
For questions about Medical Device Reporting Including Interpretation of Policy:
Address |
Phone |
|---|---|
| Reporting Systems Monitoring Branch (HFZ-533) Center for Devices and Radiological Health Food and Drug Administration 1350 Piccard Drive Rockville, MD 20850 |
(240) 276-3454 (fax)* *fax number is preferred except for emergencies |
| Voluntary Reporting Program | 240 276-3001 |
| Mandatory Reporting Program | 240 276-3000 |
Updated January 29, 2008
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