SendFAXMail

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.

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What 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.

Faxing to FDA — FAQ

The FDA's main fax is 301-443-9767, used for general inquiries. Individual centers and divisions have their own fax numbers, so check FDA.gov for the line that matches your specific submission.

Yes. MedWatch Form 3500 can be faxed to the FDA. Because it's a safety report, sending it through Send FAX Mail gives you a delivery confirmation showing the agency received it.

FOIA requests are handled by the FDA's Division of Freedom of Information. Fax your request to that division with a specific description of the records you want and your contact information so they can respond.

The FDA spreads its work across multiple centers and divisions with separate fax lines. Naming the correct center on your cover page routes the submission to the right office instead of leaving it in a general inbox.

Send FAX Mail starts at $12.99 per month with free number selection and a monthly page allowance that easily covers a MedWatch report or registration packet. If a busy reporting month exceeds your plan, you upgrade to a higher tier instead of being charged per page, and a 7-day free trial lets you send your first FDA submission before paying.

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