Form FDA 3613 FDA 3613 Supplementary Information Certificate to Foreign Governm

Form Approved: OMB No. 0910-0498; Expiration Date: 10/31/2010

SUPPLEMENTARY INFORMATION CERTIFICATE TO
FOREIGN GOVERNMENT REQUESTS

Department of Health and Human Services
Food and Drug Administration
1. Requestor Information
Name

Address

Firm

Telephone number

FAX number

Firm Tax ID code

Email address

2. Manufacturer Information
Firm

Address (P.O. Box not acceptable)

Registration number
License number (if applicable)

Date of last FDA inspection

3. Distributor Information (if applicable)
Firm

Address (P.O. Box not acceptable)

Registration number

4. Product Information
Trade name

Proper name

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

5. Was the product ever recalled?
Yes

No

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

Recall Number

Close-out Date

6. List country(ies) for which the Certificates are requested.

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

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

No

Indicate the total number of certificates requested:

9. 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 Intended for Transplantation) or “Certificate to Foreign Government” (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.
CBER instructions are on page 5.
FORM FDA 3613 (11/09)

CDRH instructions are on page 6.
Page 1 of 7

CVM instructions are on page 7.
PSC Graphics (301) 443-1090

EF

Department of Health and Human Services
Food and Drug Administration

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

Department of Health and Human Services
Food and Drug Administration

EXPORTER’S CERTIFICATION STATEMENT
(For Tissue Procured Prior to May 25, 2005)
“CERTIFICATE TO FOREIGN GOVERNMENT”
(For Human Cells Intended for Transplantation)
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, Title 21, Code of Federal Regulations Part 1270, Human Tissue Intended for Transplantation.
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 (11/09)

Page 2 of 7

Department of Health and Human Services
Food and Drug Administration

EXPORTER’S CERTIFICATION STATEMENT
(For HCT/Ps Procured After May 25, 2005)
“CERTIFICATE TO FOREIGN GOVERNMENT”
(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, Title 21, Code of Federal Regulations Part 1271, Human Cells, Tissues, and Cellular and TissueBased Products.
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 (11/09)

Page 3 of 7

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. All Facilities that appear on the certificate are 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; and
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 (21 CFR Part 820) for the identified product(s).
6. There are no HIV products listed on the certificate.
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 represents 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

FORM FDA 3613 (11/09)

Page 4 of 7

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 (procured prior to May 25,
2005, or on or after May 25, 2005) is signed by a responsible
official of the exporting firm and is enclosed with the certificate
request.
• The “Certificate of Exportability” is for the export of products
not approved for marketing in the United States (unapproved
products) that meet the requirements of Sections 801(e) or 802 of
the Act. Certificate requests should include the information listed
in Supplementary Information - Certificate of Exportability
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.
• The “Certificate of a Pharmaceutical Product” conforms to
the format established by the World Health Organization (WHO)
and is intended for use by the importing country when the product
in question is under consideration for a product license that will
authorize its importation and sale or for renewal, extension,
amending or reviewing a license. WHO Certificate requests
should include the information listed in
Supplementary
Information – Certificate of a Pharmaceutical Product
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.
• The “Non-clinical Research Use Only Certificate is for the
export of a non-clinical research use only product, material, or
FORM FDA 3613 (11/09)

component that is not intended for human use which may be marketed in, and legally exported from the United States under the
Federal, Food, Drug and Cosmetic Act. Certificate requests should
include the information listed in Supplementary Information Non-clinical Research Use Only Certificate 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 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.
• If information is omitted in the application by the requester or if
clarification is needed on the supplied information, the requester
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 301827-6201.
• 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
1401 Rockville Pike, Attention: HFM-624
Rockville, MD 20852-1448
or via FAX at 301-827-9189
• 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 FEDEX form 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.

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Department of Health and Human Services
Food and Drug Administration

INSTRUCTIONS FOR REQUESTS FOR
CERTIFICATE TO FOREIGN GOVERNMENT
(for CDRH)
1.

a.
b.
c.

d.
e.

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:
The manufacturing facility must be in compliance with the
registration requirements;
The device must be in compliance with the listing requirements;
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);
The device must meet the labeling requirements of 21 CFR Part
801 and 21 CFR 809, if applicable;
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.

9.

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
returned and will need to be resubmitted for FDA review.
11. Mark on the envelope "Request for Certificates." Please include
a completed return Fedex Air bill to expedite the return of the
certificates. Send the form along with the certificate request to:
Food and Drug Administration
CDRH - Office of Compliance
Export Certificates
10903 New Hampshire Avenue
Building 66, Room 2621
Silver Spring, MD 20993-0002

In addition, the U.S. exporter must comply with the laws of the
importing country.
2.

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

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 domestic manufacturer (in addition to the requesting
facility), whose name appears on the CFG must sign an
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.

Only hardcopy requests can be filled at this time.

FORM FDA 3613 (11/09)

If more than 3 products are to be included on the certificate, this
will necessitate the creation of additional pages. The requestor
will need to provide BOTH a paper and electronic version of this
information. 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

12. CDRH has the authority to charge $175 for the first certificate
and $15 for any subsequent certificate issued at that time, up to
a total of 50 pages (including the certificate and any attachment
pages). For example, if you request a certificate which is 10
pages in total length you may only request 5 certificates. You
will be charged $175 for the first and $15 for each of the 4
additional certificates. If your request exceeds 50 pages you
will incur additional charges.
13. Please do not submit a check with your request, as FDA will bill
you quarterly.
14. Issuance of a "Certificate to Foreign Government" will not
preclude regulatory action by FDA, if warranted, against
products covered by the Certificate.
15. A "Certificate to Foreign Government" is issued by FDA solely
for export purposes and may not be used for domestic
advertising.
16. If you have any questions, please call 301 796-7400 or email
exportcert@cdrh.fda.gov

Page 6 of 7

Department of Health and Human Services
Food and Drug Administration

INSTRUCTIONS FOR COMPLETION OF
APPLICATION FOR CERTIFICATES
(for CVM)
1.

2.

3.

4.

The Export Certificate to Foreign Governments 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. Please enclose labels for each product.
The Certificate of Exportability is for the export of products
unapproved for distribution and sale in the United States. The
requestor must meet the requirements of Section 801(e) of the
Act.

5.

Requests for certificates should be sent to:
Kim Bell
Center for Veterinary Medicine Division of
Compliance (HFV-235)
7519 Standish Place
Rockville, MD 20855
(240-276-9212- for inquiries)

6.

The “Certificate of a Pharmaceutical Product” conforms to
the format established by the World Health Organization (WHO)
and is intended for use by the importing country when the
product in question is under consideration for a product license
that will authorize its importation and sale or for renewal,
extension, amending or reviewing a license. WHO Certificate
requests should include the information listed in Supplementary
Information – Certificate of a Pharmaceutical Product
Requests. 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.

The fee for preparing and issuing a single certificate is $175;
1st duplicate original $155 and $70 for each subsequent
duplicate. No fee will be charged for animal food/feed
products. Please do not include the fee payment with your
requests; the exporting firm will be billed quarterly.

7.

The instructions and applications will be available on the CVM
Home Page (www.fda.gov/cvm/exportcertificate.htm).

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 FAX. 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 FEDEX form to expedite return
of the Certificates. A certificate will be issued for each product.

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.

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.

Paperwork Reduction Act Statement

[Applies equally to CBER, CDRH, and CVM portions of this form.]
Public reporting burden for this collection of information is estimated to average 1 hour per response, including the time for
reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and
reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection
of information, including suggestions for reducing this burden, to the address below.
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer (HFA-710)
5600 Fishers Lane
Rockville, MD 20857
[Please do NOT return this form to the above address, except as it pertains to comments on the burden estimate.]
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 control number.

FORM FDA 3613 (11/09)

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