FDA Fax Number — Fax Forms and Reports to the FDA
The U.S. Food and Drug Administration accepts faxed MedWatch adverse event reports, product complaints, facility registration documents, and drug listing forms, with a main fax number of 301-443-9767. That main line handles general inquiries, but the FDA is organized into centers and divisions that each run their own fax numbers, so a MedWatch Form 3500 and a FOIA request may go to entirely different places. Naming the right center on your cover page is what keeps a submission from sitting in the wrong queue.
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FDA Fax Number
301-443-9767
Hours: FDA fax lines available 24/7. Processing Monday-Friday, 8:00 AM - 4:30 PM ET.
Send a Fax NowWhat You Can Fax to FDA
- MedWatch adverse event reports (Form 3500)
- Product complaints
- Facility registration documents
- Drug listing forms
- FOIA requests
Tip: List the specific FDA center or division on your cover page, since the main 301-443-9767 line is meant for general inquiries rather than every submission type. For a FOIA request, send it to the FDA's Division of Freedom of Information with a clear description of the records you're after and your contact details. MedWatch Form 3500 is a safety report worth confirming delivery on, so keep the fax receipt with your records.