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FDA-3613revclean copy for OMB rvw indd

FDA-3613revclean copy for OMB rvw indd 2026

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The document outlines the procedures and requirements for obtaining Export Certificates from the FDA for products intended for export to foreign governments. It details the responsibilities of requestors, including necessary information about manufacturers, products, and compliance with U.S. regulations. Specific instructions are provided for different FDA centers (CBER, CDRH, CVM) regarding biological products, medical devices, and veterinary products. The document also includes certification statements that must be signed by responsible officials and emphasizes the importance of accurate information to avoid penalties.

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Click ‘Get Form’ to open the FDA-3613revclean copy in the editor.
Begin by filling out the 'Requestor Information' section. Enter your name, address, firm, telephone number, FAX number, and Firm Tax ID code accurately.
If your billing address differs from the requestor's, complete the 'Billing Address' section with the necessary details.
In the 'Shipping Account Number and/or Label' field, provide any relevant shipping information to facilitate mailing supplies.
For 'Manufacturer Information', enter details for each firm involved. Ensure that you include their registration numbers and last FDA inspection dates.
Complete the 'Product Information' section by providing trade names, proper names, marketing status, and product codes as applicable.
Indicate if any products were recalled and provide necessary details if applicable.
List countries for which certificates are requested and specify what product information should appear on the certificate.
Finally, ensure that all required signatures are included in the 'Exporter’s Certification Statement' before submitting your form.

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What is the FDA guidance document called every 4 years that assists state and local health officials in developing regulations?

The FDA is responsible for publishing the Food Code every four years to assist state and local health officials in developing regulations.

Are FDA records public?

The 1996 amendments to the Freedom of Information Act (FOIA) mandate publicly accessible electronic reading rooms with agency FOIA response materials and other information routinely available to the public, with electronic search and indexing features.

What is the FDA certificate of pharmaceutical product?

These certificates provide information about the drugs U.S. marketing status and the manufacturers compliance with FDAs requirements. These certificates also conform to the World Health Organization (WHO) format and are intended for importing countries considering whether to license drugs for sale in that country.

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What is the FDA accession number form?

Accession numbers are unique FDA identifiers for electronic product reports found in FDAs radiation-emitting electronic product database. FDA requires importers to provide the Accession Numbers on Form 2877. This is the one assigned by FDA to the manufacturers who made the imported electronic products.

How to find old FDA guidance documents?

FDA.gov Archive Go to the FDA.gov Web Archive page in Archive-It. Click the date for the snapshot you want to view. The FDA.gov home page appears. Browse through the site.

What is a safe to proceed letter from the FDA?

Once a sponsor submits an IND application, FDA may determine that sufficient information has been provided to allow the trial to proceed (issuing a Safe to Proceed letter), or, if there is insufficient support to assure patient safety, or if there are safety concerns, FDA can issue a clinical hold to prevent a

FDA-3613revclean copy for OMB rvw indd 2026

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