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  3. MedWatch: The FDA Safety Information and Adverse Event Reporting Program
  4. Reporting Serious Problems to FDA
  5. Where to Send Completed Form FDA 3500A MANDATORY Reporting Form
  1. Reporting Serious Problems to FDA

Where to Send Completed Form FDA 3500A MANDATORY Reporting Form

For Post-Marketing Reports

Drugs:

FDA required that applicants electronically submit all ICSRs, ICSR attachments, and periodic safety reports. Refer to FDA Adverse Events Reporting System (FAERS) Electronic Submissions for information about FDA Adverse Event Reporting System (FAERS) electronic submissions and instructions on how to electronically submit postmarketing individual case safety reports (ICSRs) with and without attachments.

Biologics, including Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps):

  • Food and Drug Administration
    Center for Biologics Evaluation and Research Document Control Center
    10903 New Hampshire Avenue WO71, G112
    Silver Spring, MD 20993-0002

Note: All postmarketing AE reports for CDER-regulated biologics cannot be submitted on a 3500A, they must be submitted electronically.

Cosmetics:

Please submit the completed MedWatch 3500A form along with information to support the report, such as scans of labels and images of the serious adverse event, to FDA via:

  • Mail:
    • FDA CDER Mail Center
      Attn: Cosmetics MedWatch reports
      White Oak Campus, Building 22, G0207
      10903 New Hampshire Ave.
      Silver Spring, MD 20993

Devices:

In accordance with CFR-Code of Federal Regulations Title 21 803.12(a), manufacturers and importers must submit initial and supplemental or follow-up reports to FDA in an electronic format that FDA can process, review, and archive. For additional information on how to enroll and submit electronic reports to FDA, please go to eMDR – Electronic Medical Device Reporting | FDA.

User facilities can but are not required to submit MDRs to the FDA in an electronic format. User facilities that prefer to submit their reports electronically, must use an electronic format that FDA can process, review and archive. For additional information on how to enroll and submit electronic reports to FDA, please go to eMDR – Electronic Medical Device Reporting | FDA.

User facilities may also submit their reports to FDA’s MDR Team at MDRPolicy@fda.hhs.gov. Alternatively, they may mail completed forms (Medwatch Form 3500A) to:  

  • Food and Drug Administration 
    Center for Devices and Radiological Health 
    Medical Device Reporting 
    8400 Corporate Drive, Suite 500  
    Landover, MD 20785

For Pre-Marketing IND Safety Reports

Adverse events involving investigational (study) drugs under Investigational New Drug (IND) applications should be reported as required in the study protocol and sent to the address and contact person listed in the study protocol. They should not be submitted to the addresses listed above unless also required (by the sponsor) under applicable postmarketing reporting regulations.

Mandatory serious adverse event [SAE] reports are to be submitted under the IND at the following addresses:

CDER INDs:

  • Food and Drug Administration
    Center for Drug Evaluation and Research
    Division of xxxx Products
    5901-B Ammendale Road
    Beltsville, MD 20705-1266

CDER-only Biologic INDs:

  • Food and Drug Administration
    Center for Drug Evaluation and Research Therapeutic Biologic Products Document Room
    5901-B Ammendale Road
    Beltsville, MD 20705-1266

CBER INDs:

  • Food and Drug Administration
    Center for Biologics Evaluation and Research Document Control Center
    10903 New Hampshire Avenue WO71, G112
    Silver Spring, MD 20993-0002

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