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:
- Email (preferred method for faster processing and reviewing):
- Mail:
- FDA CDER Mail Center
Attn: Cosmetics MedWatch reports
White Oak Campus, Building 22, G0207
10903 New Hampshire Ave.
Silver Spring, MD 20993
- FDA CDER Mail Center
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