Medical Devices

MEDWATCH Medical Device Reporting Code Instructions - Appendix A: Additional Reference and Mailing

  1. You may freely photocopy the Form 3500A. Copies are also available by mail and fax.
  2. Electronically generated versions of the form 3500A can be submitted to FDA for approval to:

    Food and Drug Administration
    Center for Devices and Radiological Health
    Information and Analysis Branch
    10903 New Hampshire Avenue
    Silver Spring, MD 20993-0002
    WO Bldg. 66 Rm. 3201

  3. The MedWatch Reporting Coding Manual is also available on the Internet.
  4. Reports sent through regular mail should be addressed to:
    Food and Drug Administration
    Center for Devices and Radiological Health
    Medical Device Reporting
    P.O. Box 3002
    Rockville, MD 20847-3002
  5. Reports that you send via an overnight carrier should be addressed to:
    FDA Center for Devices and Radiological Health
    Medical Device Reporting
    16071 Industrial Drive, Room 258
    Gaithersburg, Maryland 20877-1462

Page Last Updated: 05/28/2015
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