FDA 3613 Request for Certificate Supplementary Information

Form Approved: OMB No. 0910-0498; Expiration Date: 4/30/2024

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.
Please see page 9 for CDRH instructions on how to apply for this certificate.
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-234), 12225 Wilkins Avenue,
MPN4 #133, Rockville, MD 20852. If you have any questions, please email [email protected].
Please see page 10 for CVM instructions on how to fill out this form and apply for this certificate.

1A. Requestor Information
Name

Address

Firm
Owner operator number (if applicable)
Telephone number

FAX number

Firm Tax ID code

Email address

1C. Shipping Account Number and/or Label (Mailing supplies may
be sent along with this form.)

1B. Billing Address (if not the same as requestor)

Alternate Billing Email Address (if not the same as requestor)
2. Manufacturer Information (The following entries are to 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 (4/24)

Center for Devices and Radiological
Health (CDRH) instructions
are on page 9.
Page 1 of 10

Center for Veterinary Medicine (CVM)
instructions are on page 10.

PSC Publishing Services (301) 443-6740

EF

2. 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

3. 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)

4. Product Information
Trade name

Proper name

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

FORM FDA 3613 (4/24)

Page 2 of 10

5A. Was the product ever recalled?
Yes

No

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

5A. Was the product ever recalled? (Continued)
Recall Number

Close-out Date

(Note: Include recalls from the past 10 years.)

Close-out Date

Recall Number

Close-out Date

5B. Are any of the manufacturers under Injunction?
Yes

No

If yes, provide registration or FEI number:

5C. Are any of the products under Seizure?
Yes

No

If yes, provide product name:

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

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 unless requested.)
Yes

FORM FDA 3613 (4/24)

No

Indicate the total number of certificates requested:
Page 3 of 10

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 (4/24)

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

(Human Cells, Tissues and Cellular and Tissue-Based
Products Regulated Solely under Section 361 of the Public
Health Service Act)
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 establishment, 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 Title 21, Code of Federal Regulations Part 1271, Human Cells, Tissues, and Cellular and Tissue-Based 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 (4/24)

Page 5 of 10

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;
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 (4/24)

Page 6 of 10

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;
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 (4/24)

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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 certifications 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 export
certification issued.

General Instructions:
• The “Certificate to Foreign Government” is an export
certification for 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 (HCT/Ps) 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 "Human Cells, Tissues and Cellular and Tissue Based
Products" certificate is for the export of HCT/Ps that are regulated
solely under section 361 of the Public Health Service Act and are
in compliance with the applicable sections of Title 21, Code of
Federal Regulations Part 1271 (21 CFR 1271)
• 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 application 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.

• Questions may be directed to the Import/Export Team at 240-4029155 or by email at [email protected].
• 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 requestor, 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 [email protected] . 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.

• If information is omitted in the application by the requestor or if
clarification is needed on the supplied information, the requestor
will be contacted. If the requestor 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.
FORM FDA 3613 (4/24)

Page 8 of 10

Department of Health and Human Services
Food and Drug Administration

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

7. If requested, you will need to show proof that a device was
offered for sale prior to May 28, 1976.
8. Request a Certificate to Foreign Government using our
electronic system, the CDRH Export Certification Application
and
Tracking
System
(CECATS)
at https:/www.
access.fda.gov/oaa. If you have any problems please contact
us at [email protected].
9. 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.
10. 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.
11. CDRH has the authority to charge $175.00 for the first certificate
and $85.00 each for the subsequent copies. The FDA will bill you
quarterly.
12. Issuance of a “Certificate to Foreign Government” will not
preclude regulatory action by FDA, if warranted, against products
covered by the Certificate.
13. If you have any questions, please call 301 796-7400, option 3,
or email [email protected].

4. A representative of the requesting facility must provide a
signed Exporter’s Certification Statement. In Section 1A, the
requestor should also provide the owner operator number of the
registered establishment that he represents.
5. All contract manufacturers and contract sterilizers involved in
the manufacturing process must be identified on the application
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.
FORM FDA 3613 (4/24)

Page 9 of 10

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.

4. Requests for certificates should be sent to:
Food and Drug Administration
Center for Veterinary Medicine
Division of Compliance (HFV-234)
12225 Wilkins Avenue, MPN4 #133
Rockville, MD 20852
[email protected] – for inquiries)
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.

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.
• Errors made in the application, by the submitter, cannot be
corrected. A new application must be submitted.

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 Operations
Paperwork Reduction Act (PRA) Staff
[email protected]
“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 (4/24)

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