Form FDA 3613 FDA 3613 Supplementary Information Certificate to Foreign Governm

Form Approved: OMB No. 0910-0498; Expiration Date: xx/xx/201x

SUPPLEMENTARY INFORMATION
CERTIFICATE TO FOREIGN GOVERNMENT REQUESTS

Department of Health and Human Services
Food and Drug Administration

Send the Export Certificate Requests and supporting documents to the appropriate Center within FDA that would have
control over your product:
CBER: CBER regulates biological products, including blood and blood products, vaccines, allergenics, tissues, and
cellular and gene therapies. CBER also regulates the medical devices involved in the collection, processing, testing,
manufacture and administration of licensed blood, blood components and cellular products and all HIV test kits used
both to screen donor blood, blood components, and cellular products and to diagnose, treat, and monitor persons with
HIV and AIDS. Please apply for your application using https://www.access.fda.gov/oaa. Please see page 8 for CBER
instructions on how to apply for this certificate.
CDRH: CDRH regulates devices ranging from thermometers to kidney dialysis machines and electronic products
that emit radiation such as microwaves. Please submit your application online using https://www.access.fda.gov/oaa.
Complete pages 1,2,3 and 7 for devices. Please see page 9 for CDRH instructions.
Please submit your request preferably online using CECATS, or by U.S. Mail if unable to use CECATS.
CVM: Feed/food, drugs and devices used in pets, farm animals, and other animals are regulated by the Food and
Drug Administration, Center for Veterinary Medicine, Division of Compliance (HFV-235), 7519 Standish Place
Rockville, MD 20855. If you have any questions, please call 240-276-9227 or email CVMExportCertification@fda.
hhs.gov. Please see page 11 for CVM instructions on how to fill out this form and apply for this certificate.
1. Requestor Information
Name

Address

Firm

Telephone number

FAX number

Firm Tax ID code

2. Billing Address (if not the same as requestor)

Email address

3. Shipping Account Number and/or Label (Mailing supplies may
be sent along with this form.)

4. Manufacturer Information (The following entries are be entered separately for each firm; multiple entry sets are provided)
Firm

Address (P.O. Box not acceptable)

Registration number/Firm Establishment Identifier (FEI)

License number (if applicable)

Date of last FDA inspection

(Item 4 entry sets continued, next page)

Center for Biologics Evaluation and
Research (CBER) instructions
begin on page 8.
FORM FDA 3613 (2/15)

Center for Devices and Radiological
Health (CDRH) instructions
are on page 9.
Page 1 of 11

Center for Veterinary Medicine (CVM)
instructions are on page 11.

PSC Publishing Services (301) 443-6740

EF

4. Manufacturer Information (Continued)
Firm

Address (P.O. Box not acceptable)

Registration number/Firm Establishment Identifier (FEI)

License number (if applicable)

Date of last FDA inspection

Firm

Address (P.O. Box not acceptable)

Registration number/Firm Establishment Identifier (FEI)

License number (if applicable)

Date of last FDA inspection

Firm

Address (P.O. Box not acceptable)

Registration number/Firm Establishment Identifier (FEI)

License number (if applicable)

Date of last FDA inspection

Firm

Address (P.O. Box not acceptable)

Registration number/Firm Establishment Identifier (FEI)

License number (if applicable)

Date of last FDA inspection

Firm

Address (P.O. Box not acceptable)

Registration number/Firm Establishment Identifier (FEI)

License number (if applicable)

Date of last FDA inspection

5. Distributor Information (If applicable. Any firm listed must have a U.S. address.)
Firm

Address (P.O. Box not acceptable)

Registration number/Firm Establishment Identifier (FEI)

6. Product Information
Trade name

Proper name

Marketing status (BLA/STN, HDE, NADA, ANADA, NDA, PDP, PMA, or 510k preamendment
or exempt – Include number and date approved)

Product code (if applicable)

7. Was the product ever recalled?
Yes

No

If “Yes”, state the recall number
and close-out date:
Recall Number

FORM FDA 3613 (2/15)

Page 2 of 11

Close-out Date

7. Was the product ever recalled?
Yes

If “Yes”, state the recall number and close-out date. (Note: Include recalls from the past 10 years.)

No

Recall Number

Close-out Date

Recall Number

Close-out Date

8. List country(ies) for which the Certificates are requested. List at least one country.

9. Indicate what product information should appear on the certificate.

10. Should the country destination be listed on the certificate? (Note: CDRH does not list a specific country unless requested.)
Yes

No

Indicate the total number of certificates requested:

11. NOTE: If the product(s) being exported is human tissue intended for transplantation or an HCT/P, please ensure the appropriate
Exporter’s Certification Statement, “Certificate to Foreign Government” (For Human Tissue or Human Cells, Tissues and Cellular and
Tissue-Based Products) is signed by a responsible official of the exporting firm and is enclosed with the certificate request.
FORM FDA 3613 (2/15)

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Department of Health and Human Services
Food and Drug Administration

EXPORTER’S CERTIFICATION STATEMENT
“CERTIFICATE TO FOREIGN GOVERNMENT”
for CVM

FIRM NAME

As the responsible official or designee of the company named above, I hereby certify to the United States Food and
Drug Administration that the company, the manufacturing plant, and the product(s) being exported, as identified in the
Supplementary Information, continue to be, to the best of my knowledge, in compliance with all applicable requirements
of the Federal Food, Drug, and Cosmetic Act, and all applicable or pertinent regulations including the following:
1. Facilities that appear on the certificate are currently registered with the FDA.
2. Each product(s) identified for export is legally marketed within the United States.
3. Each product(s) identified is not the subject of an open recall or the subject of any current enforcement action
initiated by FDA;
4. All manufacturers, contract manufacturers, and contract sterilizers involved in the manufacturing process have
been identified on the 3613 form;
5. The requesting facility and all facilities involved in the manufacturing process are operating in substantial
compliance with the Good Manufacturing Practices Regulation for the identified product(s); and
6. Each product(s) identified for export is being exported from the United States.
SIGNATURE

DATE

NAME AND TITLE

Making or submitting false statements on any documents submitted to FDA may constitute violations of the United
States Code Title 18, Chapter 47, Section 1001 with penalties including up to $250,000 in fines and up to 5 years
imprisonment.
FORM FDA 3613 (2/15)

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EXPORTER’S CERTIFICATION STATEMENT
Department of Health and Human Services
Food and Drug Administration

“CERTIFICATE TO FOREIGN GOVERNMENT”
(For Human Tissues or Human Cells, Tissues and Cellular
and Tissue-Based Products)
for CBER

FIRM NAME

As the responsible official or designee of the company named above, I hereby certify to the United States Food and
Drug Administration that the company, the manufacturing plant, and the product(s) being exported, as identified in the
Supplementary Information, continue to be, to the best of my knowledge, in compliance with all applicable requirements
of FDA regulation. (Select applicable regulation for Human Tissue for Transplant or HCT/Ps below.)
Title 21, Code of Federal Regulations Part 1270,
Human Tissue intended to Transplantation (For
Human Tissue procured before May 25, 2005)

Title 21, Code of Federal Regulations Part 1271,
Human Cells, Tissues, and Cellular and Tissue-Based
Products (For HCT/Ps Procured After May 25, 2005)

SIGNATURE

DATE

NAME AND TITLE

Making or submitting false statements on any documents submitted to FDA may constitute violations of the United
States Code Title 18, Chapter 47, Section 1001 with penalties including up to $250,000 in fines and up to 5 years
imprisonment.
FORM FDA 3613 (2/15)

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Department of Health and Human Services
Food and Drug Administration

EXPORTER’S CERTIFICATION STATEMENT
“CERTIFICATE TO FOREIGN GOVERNMENT”
for CBER

FIRM NAME

As a responsible official or designee authorized to represent and act on behalf of the facility named immediately above,
I hereby certify to the Food and Drug Administration (FDA) that the facility(s) and the products identified on the
Supplemental Information are to the best of my knowledge in substantial compliance with the Federal Food, Drug, and
Cosmetic Act (the Act) and all applicable or pertinent regulations including the following:
1. All Facilities that appear on the certificate are currently registered and each facility has listed each of its products
identified for export as required by Section 510 of the Act and 21 CFR Part 207, 607, or 807 (see attached
Supplementary Information Page);
2. Each product(s) identified for export is legally marketed within the United States and is the subject of a Biologics
License, NDA, ANDA, PMA or 510(k) premarket notification or is a device that was in commercial distribution
before May 28, 1976, or exempt, or is the subject of a premarket approval application;
3. Each product(s) identified is not subject of an open recall or the subject of any current enforcement action
initiated by FDA;
4. All manufacturers, contract manufacturers, and contract sterilizers involved in the manufacturing process have
been identified on the 3613 form;
5. The requesting facility and all facilities involved in the manufacturing process are operating in substantial
compliance with the Good Manufacturing Practices Regulation for the identified product(s); and
6. Each product(s) identified for export is being exported from the United States.
I hereby make this certification of compliance statement to FDA with full knowledge that the making or submission of
false statements represent violations of United States Code Title 18, Chapter 47, Section 1001. Penalties include up to
$250,000 in fines and up to five years imprisonment.
SIGNATURE

DATE

NAME AND TITLE

Making or submitting false statements on any documents submitted to FDA may constitute violations of the United
States Code Title 18, Chapter 47, Section 1001 with penalties including up to $250,000 in fines and up to 5 years
imprisonment.
FORM FDA 3613 (2/15)

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Department of Health and Human Services
Food and Drug Administration

EXPORTER’S CERTIFICATION STATEMENT
“CERTIFICATE TO FOREIGN GOVERNMENT”
for CDRH

NAME OF FACILITY

As a responsible official or designee authorized to represent and act on behalf of the facility named immediately above,
I hereby certify to the Food and Drug Administration (FDA) that the facility(s) and the products identified on the
Supplemental Information are to the best of my knowledge in substantial compliance with the Federal Food, Drug, and
Cosmetic Act (the Act) and all applicable or pertinent regulations including the following:
1. Each facility that appears on the certificate is currently registered and each facility has listed each of its
medical devices identified for export as required by Section 510 of the Act and 21 CFR Part 807 (see attached
Supplementary Information Page);
2. Each product(s) identified for export is legally marketed within the United States and is the subject of a 510(k)
premarket notification or is a device that was in commercial distribution before May 28, 1976, or exempt, or is
the subject of a premarket approval application;
3. Each product(s) identified is not subject of an open recall or the subject of any current enforcement action
initiated by FDA;
4. Manufacturers, contract manufacturers, and contract sterilizers involved in the manufacturing process have been
identified on the 3613 form , if applicable;
5. The requesting facility and all facilities involved in the manufacturing process are operating in substantial
compliance with the Good Manufacturing Practices Regulation (21 CFR Part 820) for the identified product(s);
6. There are no HIV products listed on the certificate; and
7. Each product(s) identified for export is being exported from the United States.
I hereby make this certification of compliance statement to FDA with full knowledge that the making or submission of
false statements represent violations of United States Code Title 18, Chapter 47, Section 1001. Penalties include up to
$250,000 in fines and up to five years imprisonment.
SIGNATURE

DATE

NAME AND TITLE

Making or submitting false statements on any documents submitted to FDA may constitute violations of the United
States Code Title 18, Chapter 47, Section 1001 with penalties including up to $250,000 in fines and up to 5 years
imprisonment.
FORM FDA 3613 (2/15)

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Department of Health and Human Services
Food and Drug Administration

EXPORT CERTIFICATION
Submission Requirements for Requesting Certificates for
Exporting Products to Foreign Countries (for CBER)
Background
Firms exporting products from the U.S. are often asked by foreign
customers or foreign governments to supply a certification relating
to products subject to the Federal Food, Drug, and Cosmetic Act and
other acts the Food and Drug Administration (FDA) administers.
Under the FDA Export Reform and Enhancement Act of 1996
(the Act), FDA is authorized to issue certificates for drugs, animal
drugs, and devices within 20 days of receipt of a request for such a
certificate. A fee of up to $175 may be charged for each certificate
issued. In addition to issuing export certificates for approved or
licensed products, the FDA will also issue export certificates for
unapproved products that meet the requirements of Sections 801(e)
or 802 of the Act.

General Instructions:
• The “Certificate to Foreign Government” is for the export
of products legally marketed in the United States. Certificate
requests should include the information listed in Supplementary
Information – Certificate to Foreign Government Requests
(PDF, Text). Please ensure that the Exporter’s Certification
Statement is signed by a responsible official of the exporting firm
and is enclosed with the certificate request. Please ensure that
the appropriate Exporter Certification Statements for Certificate
to Foreign Government Requests for Human Cells, Tissues, and
Cellular and Tissue-Based Products is signed by a responsible
official of the exporting firm and is enclosed with the certificate
request.
• The “Certificate to Foreign Government (For Human Cells
Intended for Transplantation)” is for the export of human tissues
that were procured prior to May 25, 2005, which can be legally
marketed in the United states.
• The “Certificate to Foreign Government (Human Cells, Tissues
and Cellular and Tissue-Base Products)” is for the export of
HCT/Ps that were procured after to May 25, 2005, which can be
legally marketed in the United states.
• Please type certificate requests or print clearly.
• In most cases, one product will be listed per certificate. However,
products that were approved under the same PLA / BLA, NDA,
PMA or 510(k) application or similar unapproved products may be
listed on the same certificate based on the available space for a one
page certificate. Certificate requests for listing multiple products
will be evaluated on a case-by-case basis.

will be contacted via telephone or FAX. If the requester does not
provide the necessary information within 48 hours, the request for
certificates will be returned and will need to be resubmitted for
FDA review.
• Questions may be directed to the Import/Export Team at 240-4029155 or by email at CBERBECATS@fda.hhs.gov. .
• Errors made by FDA during the preparation of export certificates
will be corrected, at no cost to the applicant, within 45 days after
issuance.
– Errors made in the application, by the submitter, cannot be
corrected. A new application must be submitted.
• Request an Export Certificate using one of the following methods.
To facilitate your certificate request, please apply for your
application using https://www.access.fda.gov/oaa. Create a new
account and select the Biologics Export Certificate Application
and Tracking System (BECATS). If you have any problems, then
please contact us at HYPERLINK “mailto:CBERBECATS@fda.
hhs.gov” CBERBECATS@fda.hhs.gov. You may also send the
request and supporting documents to:
Food and Drug Administration
Center for Biologics Evaluation and Research
Office of Compliance and Biologics Quality
Division of Case Management
10903 New Hampshire Ave.
Building 71, Room G112
Silver Spring, MD 20993-0002
• On October 1, 1996, CBER was given the authority to charge $175
for the first two certificates and $85 for any subsequent certificates
issued for the same product(s) in response to the same certificate
request. Please do not submit a check with your request, as FDA
will bill you quarterly for issued certificates.
• You may enclose a completed air billing number and mailing
supplies to expedite the return of Certificates.
Issuance of a “Certificate to Foreign Government”, “Certificate
of Exportability” or “Certificate of a Pharmaceutical Product”
will not preclude regulatory action by FDA, if warranted, against
products covered by the Certificate.
A “Certificate to Foreign Government”, “Certificate of
Exportability” or “Certificate of a Pharmaceutical Product” is
issued by FDA solely for export purposes and may not be used
for domestic advertising.

• If information is omitted in the application by the requester or if
clarification is needed on the supplied information, the requester

FORM FDA 3613 (2/15)

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Department of Health and Human Services
Food and Drug Administration

INSTRUCTIONS FOR PAPER REQUESTS FOR
CERTIFICATE TO FOREIGN GOVERNMENT
(for CDRH)
1. Please note these instructions are for requests that are submitted
through U.S. Mail. Any medical device that is legally marketed in
the United States (U.S.) may be exported anywhere in the world
without prior Food and Drug Administration (FDA) notification
or approval. The Certificate to Foreign Government (CFG) is for
the export of products legally marketed in the U.S. For a device
to be legally in commercial distribution in the U.S., the following
requirements must be met:
a. The manufacturing facility must be in compliance with the
registration requirements;
b. The device must be in compliance with the listing
requirements;
c. The device must have a cleared Premarket Notification 510(k)
or Premarket Approval (PMA) unless exempted by regulation
or if the device was on the market prior to May 28, 1976
(before the Medical Device Amendments to the FD&C Act);
d. The device must meet the labeling requirements of 21 CFR
Part 801 and 21 CFR 809, if applicable;
e. The device must be manufactured in accordance with the
Quality Systems (QS) Regulation or 21 CFR Part 820 (also
known as Good Manufacturing Practices or GMP), unless
exempted by regulation.
In addition, the U.S. exporter must comply with the laws of the
importing country.

9. If more than three products are to be included on the certificate,
this will necessitate the creation of additional pages.
Explanation of the three product limit on the certficate: The
reason FDA wants only three products is to avoid typing errors
and to ensure that the certificate looks neat. If the product names
are long we suggest you create an attachment page. Essentially,
FDA wants you to minimize the writing on the certificate page.
Please note that all firms appearing on the actual certificate must
also appear on these additional pages. If you have questions about
how to format these pages, please send an email to: exportcert@
cdrh.fda.gov.
10. If information is omitted in the application by the requestor or
if clarification is needed, the requestor will be contacted via
email or phone. If the requestor does not supply the necessary
information within 48 hours, the request for certificates will be
closed and will need to be resubmitted for FDA review.
11. Errors made by FDA during the preparation of export certificates
will be corrected at no cost to the applicant within 45 days after
issuance.
• Errors made in the application, by the submitter, cannot be
corrected. A new application must be submitted.
12. Mark on the envelope “Request for Certificates.” Please include
the electronic return UPS or FedEx label that FDA can use to mail
the certificates to you. Send the form along with the certificate
request to:

2. All products listed on a CFG must be exported from the U.S.

Food and Drug Administration
CDRH - Office of Compliance
Export Certificates
10903 New Hampshire Avenue
Building 66, Room 2621
Silver Spring, MD 20993-0002

3. Each CFG request must be submitted by a U.S. firm. Requests
received from a foreign firm will not be considered. A U.S. firm
must appear on each CFG.
4. Any facility, both domestic and foreign (in addition to the
requesting facility) included on the certificate must provide a
signed Exporter’s Certification Statement.
5. All contract manufacturers and contract sterilizers involved in
the manufacturing process must be identified on the 3613 form
regardless if they are to appear on the certificate.
6. It is the requestor’s responsibility to ensure that the information
on the certificate is supplied correctly, including spelling.
7. If requested, you will need to show proof that a device was offered
for sale prior to May 28, 1976.
8. There are two options in requesting a Certificate to Foreign
Government. Submit a request through our electronic system,
the CDRH Export Certification Application and Tracking System
(CECATS) at https:/www.access.fda.gov/oaa, or through the U.S.
mail if unable to use CECATS.
Please only send your request using one of these two methods:
through our electronic system CECATS, or by U.S. Mail.
FORM FDA 3613 (2/15)

13. CDRH has the authority to charge $175.00 for the first certificate
and $15.00 each for the subsequent copies. This is valid for
requests that are up to 50 pages each. Certificate includes the
certificate page and the attachment pages.
If the request is more than 50 pages, then the total number of
pages created by the request is divided by 50 and that number
will be the number of certificates that will be charged at $175.00
and the remaining number of certificates will be charged at
$15.00 each.
Example: If you request 15 certificates and each certificate has
12 attachment pages plus the certificate page that means each
certificate is 13 pages, your request will generate 195 pages in
all, this number will be divided by 50 that equals 3.9 which is
rounded to 4. Therefore, you will be charged for 4 certificates at
$175.00 each and the remaining 11 at $15.00 each.
Please note the maximum number of attachment pages is 49
pages. If you have more than 49 pages you will need to split the
request to two requests.

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Instructions For Paper Requests for Certificate to Foreign Government (for CDRH) (Continued)

14. Please do not submit a check with your request, as FDA will bill
you quarterly.

17. If you have any questions, please call 301 796-7400 or email
exportcert@cdrh.fda.gov.

15. Issuance of a “Certificate to Foreign Government” will not
preclude regulatory action by FDA, if warranted, against products
covered by the Certificate.

18. Please use a separate sheet to list any information that does not fit
on the Supplementary Information due to lack of space, you may
list the heading as “Attachment to Supplementary Information,”
e.g., contract manufacturer/contract sterilizer information,
product information, etc.

16. A “Certificate to Foreign Government” is issued by FDA solely
for export purposes and may not be used for domestic advertising.
FORM FDA 3613 (2/15)

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Department of Health and Human Services
Food and Drug Administration

INSTRUCTIONS FOR COMPLETION OF
APPLICATION FOR CERTIFICATES TO FOREIGN GOVERNMENTS
(for CVM)
1. The Certificate to Foreign Government is for the export of
products legally marketed in the United States. An application
form must be completed and signed. The form is to be completed
by the responsible head or designee of the exporting firm. Enclose
labels for each product.
2. If the requested information on the application form is not
provided by the exporting firm or if clarification is needed on
the supplied information, the exporting firm will be contacted
via telephone or email. If the exporting firm does not provide the
necessary information within 48 hours, the request for certificates
will be returned and will need to be resubmitted. You may enclose
a completed air billing number and mailing supplies to expedite
return of the Certificates. A certificate will be issued for each
product.
3. Errors made by FDA during the preparation of export certificates
will be corrected, at no cost to the applicant, within 45 days after
issuance.

5. The fee for preparing and issuing each certificate is $175; the first
duplicate of that original is $155; and $70 for each subsequent
duplicate per request. The fee for preparing and issuing each
certificate for animal feed/food will not exceed $175. Please do
not include the fee payment with your requests; the exporting
firm will be billed quarterly.
PLEASE NOTE: Making or submitting false statements on any
documents submitted to FDA represents violations of the United
States Code, Title 18, Chapter 47, Section 1001 with penalties
including up to $10,000 in fines and up to 5 years imprisonment.
Issuance of an Export Certificate for Approved Products or
Certificate of Exportability will not preclude regulatory action by
FDA, if warranted, against products covered by the Certificate.
Certificates issued by the FDA are solely for export purposes and
may not be used for domestic advertising.

• Errors made in the application, by the submitter, cannot be
corrected. A new application must be submitted.
4. Requests for certificates should be sent to:
Food and Drug Administration
Center for Veterinary Medicine
Division of Compliance (HFV-235)
7519 Standish Place
Rockville, MD 20855
(240-276-9227 or
CVMExportCertification@fda.hhs.gov – for inquiries)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 1 hour per response, including the time to review
instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of
information. Send comments regarding this burden estimate or any other aspect of this information collection, including
suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
“An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number.”

FORM FDA 3613 (2/15)

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