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) 847-8543 |
| 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:
For Questions about Medical Device Reporting, including Interpretation of policy:
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Address
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Phone
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| 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: RSMB@fda.hhs.gov (301) 796-6670 (voice) |
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