FDA 3613a Supplementary Information Certificate of Exportability R

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

SUPPLEMENTARY INFORMATION
CERTIFICATE OF EXPORTABILITY 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 see pages 7 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 on line using https://www.access.fda.gov/oaa.
Please see page 8 for CDRH instructions on the 801 Certificate. Please see page 9 for CDRH instructions for the 802
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

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

Email address

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

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)
Address (P.O. Box not acceptable)

Firm

Registration number/Firm
Establishment Identifier (FEI)

Date of last FDA inspection

(Item 4 entry sets continued, next page)

Center for Biologics Evaluation and Research (CBER)
instructions are on page 7.

Center for Devices and Radiological Health (CDRH)
instructions for 802 are on page 9.

Center for Devices and Radiological Health (CDRH)
instructions for 801(e)(1) begin on page 8.

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

FORM FDA 3613a (4/24)

Page 1 of 10

PSC Publishing Services (301) 443-6740

EF

2. Manufacturer Information (Continued)
Address (P.O. Box not acceptable)

Firm

Registration number/Firm
Establishment Identifier (FEI)

Date of last FDA inspection

Firm

Address (P.O. Box not acceptable)

Registration number/Firm
Establishment Identifier (FEI)

Date of last FDA inspection

Firm

Address (P.O. Box not acceptable)

Registration number/Firm
Establishment Identifier (FEI)

Date of last FDA inspection

Firm

Address (P.O. Box not acceptable)

Registration number/Firm
Establishment Identifier (FEI)

Date of last FDA inspection

Firm

Address (P.O. Box not acceptable)

Registration number/Firm
Establishment Identifier (FEI)

Date of last FDA inspection

Firm

Address (P.O. Box not acceptable)

Registration number/Firm
Establishment Identifier (FEI)

Date of last FDA inspection

3. Product Information
Product name

Does the product have an
approved IDE?
If yes, provide IDE number:

Product class
Class 1

Class 2

Class 3

4. List country(ies) for which the Certificates are requested. Please list at least list one country.

FORM FDA 3613a (4/24)

Page 2 of 10

Yes

No

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

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

No

Indicate the total number of certificates requested:

7. Are you exporting pursuant to section 801(e) or section 802 of the Act?
To section 801(e)

To section 802

NOTE: To meet the requirements for exporting products pursuant to section 802 of the Act, an exporter must maintain records of the
product(s) exported and the countries to which they were exported. Notification of exporting unapproved drugs or devices, including
biologics, pursuant to section 802(g) of the Act is separate from requesting or receiving a Certificate of Exportability. Notification to FDA
is required when the exporter first begins to export and should be sent to the same address for requesting export certificates.
FORM FDA 3613a (4/24)

Page 3 of 10

Department of Health and Human Services
Food and Drug Administration

EXPORTER’S CERTIFICATION STATEMENT
“CERTIFICATE OF EXPORTABILITY”
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:
1. The product(s) accords to the specifications of the foreign purchaser;
2. The product(s) is not in conflict with the laws of the country to which it is intended for export;
3. The product(s) is labeled on the outside of the shipping package that it is intended for export;
4. The product(s) is not sold or offered for sale in the United States;
5. Each product(s) identified on the request and certificate is being exported from the United States;
6. All contract manufacturers, contract sterilizers, etc. involved in the manufacturing process have been identified
on the 3613a form,; and
7. The manufacturer is currently registered and has listed each of its products identified for export as required by
section 510 of the Act and CFR Part 207, 607, 807.
(Check below, if exporting under Section 802 of the Act.)
In addition, I hereby certify to the FDA that pursuant to Section 802(f)(1) of the Act, the product(s) being
exported has been manufactured, processed, packaged, and held in substantial conformity with current good
manufacturing practice requirements.
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 3613a (4/24)

Page 4 of 10

Department of Health and Human Services
Food and Drug Administration

EXPORTER’S CERTIFICATION STATEMENT
“CERTIFICATE OF EXPORTABILITY” for
CDRH [Section 801(e)(1)]

NAME OF FACILITY

As a responsible official or designee authorized to represent and act on behalf of the requesting 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 compliance with the Federal Food, Drug,
and Cosmetic Act (the Act) and all applicable or pertinent regulations including the following:
1. Each product(s) identified for export accords to the specification of the foreign purchaser; 801(e)(1)(A);
2. Each product(s) identified is not in conflict with the laws of the country to which it is intended for export; 801
(e)(1)(B);
3. The product(s) is labeled on the outside of the shipping package that it is intended for export; 801(e)(1)(C);
4. The product(s) is not sold or offered for sale in domestic commerce (the United States); 801(e)(1)(D);
5. All contract manufacturers and contract sterilizers involved in the manufacturing process have been identified on
the 3613a form;
6. The manufacturer is currently registered and has listed each of its medical devices identified for export as
required by section 510 of the Act and CFR Part 807;
7. The requesting facility has not listed any HIV products on the certificate;
8. Each product(s) identified on the certificate is a Class I or II product; and
9. Each product(s) identified on the certificate 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 3613a (4/24)

Page 5 of 10

Department of Health and Human Services
Food and Drug Administration

EXPORTER’S CERTIFICATION STATEMENT
“CERTIFICATE OF EXPORTABILITY”
for CDRH (Section 802)

NAME OF FACILITY

8. Each product(s) identified is not in conflict with the laws
of the country to which it is intended for export; 801(e)
(1)(B);

As a responsible official or designee authorized to represent
and act on behalf of the requesting facility named immediately
above, I hereby certify to the Food and Drug Administration
(FDA) that the facility(s) and the products identified on the
attached application for a Certificate of Exportability Section
802 are to the best of my knowledge in substantial compliance
with Section 802 of the Federal Food, Drug, and Cosmetic Act
(the Act) and all applicable or pertinent regulations including
the following:

10. The product(s) is not sold or offered for sale in domestic
commerce (the United States); 801(e)(1)(D);

1. The manufacturer is currently registered and has listed
each of its medical devices identified for export as
required by section 510 of the Act and CFR Part 807;

11. The product(s) identified is not an imminent hazard to
health of the country to which the product would be
exported, as notified by the Secretary; 802(f) (4)(B);

2. All contract manufacturers and contract sterilizers
involved in the manufacturing process have been
identified on the 3613a form;

12. The product(s) identified is labeled in accordance with
the requirements of the Tier 1 Country (country granting
valid marketing authorization under 802(b)), as well as
the requirements of any other country to which the device
would be exported (including language requirements and
units of measure), 802(f)(5);

3. Each product identified for export is manufactured
substantially in accordance with good manufacturing
practices or international quality systems standards
recognized by the Secretary; 802(f)(1);
4. Each product(s) identified is not adulterated by containing
any filth, putrid or decomposed substance in whole or in
part; 501(a)(1);
5. Each product(s) identified is not prepared, packed or
held under insanitary conditions whereby it may be
contaminated with filth or rendered injurious to health;
501(a)(2)(A);
6. Each product(s) container does not contain any poisonous
or deleterious substance which may render the device
injurious to health; 501(a)(3);
7. Each product(s) identified for export accords to the
specification of the foreign purchaser; 801(e)(1)(A);

9. The product(s) is labeled on the outside of the shipping
package that is intended for export; 801(e) (1)(C);

13. The product(s) identified is promoted in accordance
with labeling requirements of 802(f)(5); 802(f)(6);
14. The requesting facility has not listed any HIV products
on the certificate;
15. Each product(s) identified on the certificate is being
exported from the United States; and
16. Each product identified is a Class III device or is a
banned device.
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

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 3613a (4/24)

Page 6 of 10

Department of Health and Human Services
Food and Drug Administration

EXPORT CERTIFICATION
Submission Requirements for Requesting Certifi cates 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. In addition to issuing export certification
certificates for approved or licensed products, the FDA will also issue
export certification certificates for unapproved products that meet the
requirements of Sections 801(e) or 802 of the Act.

General Instructions:
• The “Certificate of Exportability” is an export certification for
products that are 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.
• Please type certificate requests or print clearly.
• In most cases, one product will be listed per certificate. However,
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 caseby-case basis.

• 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.
• Questions may be directed to the Import/Export Team at 240402-9155 or by email at [email protected].
• Send the request and supporting documents to
[email protected] or you can mail 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 3613a (4/24)

Page 7 of 10

Department of Health and Human Services
Food and Drug Administration

INSTRUCTIONS FOR CERTIFICATE OF
EXPORTABILITY [Section 801(e)(1)] (for CDRH)
1. The Certificate of Exportability Section 801(e)(1) is for the
export of products not approved for marketing in the United
States that meet the requirements of Section 801(e)(1) of the
Federal Food, Drug, and Cosmetic Act. Among the requirements
to be met prior to the issuance of this certificate are the following:
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 meet the requirements of Section 801(e):
(A) accords to the specifications of the foreign purchaser,
(B) is not in conflict with the laws of the country to which
it is intended for export,
(C) is labeled on the outside of the shipping package that it
is intended for export, and
(D) is not sold or offered for sale in domestic commerce.
In addition, the U.S. Exporter must comply with the laws of
the importing country.
2. Please ensure that the Exporter’s Certification Statement is
signed by a responsible official of the requesting firm.
3. All products listed on a Certificate of Exportability must be
exported from the U.S.
4. Each Certificate of Exportability request must be submitted
by a U.S. manufacturer only, whose name must appear on the
certificate.
5. The requestor should provide the owner operator number for
the registered manufacturer that he represents.

7. It is the requestor’s responsibility to ensure that the information
is supplied correctly, including spelling.
8. Request a Certificate of Exportatility using our electronic
system, the CDRH Export Certification Application and
Tracking System (CECATS) at https:/www.access.fda.gov/oaa.
If you have problems, please contact us at CDRHCECATS@fda.
hhs.gov.
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 of Exportability” 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].

6. All contract manufacturers and contract sterilizers involved in the
manufacturing process must be identified on the form regardless
if they are to appear on the certificate.

FORM FDA 3613a (4/24)

Page 8 of 10

Department of Health and Human Services
Food and Drug Administration

INSTRUCTIONS FOR CERTIFICATE OF
EXPORTABILITY (SECTION 802) (for CDRH)

1. The Certificate of Exportability Section 802 is for the export of
products not approved for marketing in the United States that
meet the requirements of Section 801(e)(1) and Section 802 of the
Federal Food, Drug, and Cosmetic Act. Among the requirements
to be met prior to the issuance of this certificate are the following:
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 meet the requirements of Section 801(e):
(A) accords to the specifications of the foreign purchaser,
(B) is not in conflict with the laws of the country to which
it is intended for export,
(C) is labeled on the outside of the shipping package that it
is intended for export, and
(D) is not sold or offered for sale in domestic commerce.

7. It is the requestor’s responsibility to ensure that the information is
supplied correctly, including spelling.
8. Request a Certificate of Exportatility using our electronic
system, the CDRH Export Certification Application and
Tracking System (CECATS) at https:/www.access.fda.gov/oaa.
If
you
have
problems,
please
contact
us
at
[email protected].
9. If more than one product/manufacturer is to be included on the
certificate, this will necessitate the creation of additional pages.
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.

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

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.

2. Please ensure that the Exporter’s Certification Statement is
signed by a responsible official of the requesting firm.

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

3. All products listed on a Certificate of Exportability must be
exported from the U.S.

12. CDRH has the authority to charge $175.00 for each original
certificate and $85.00 for any subsequent original certificate.
The FDA will bill you quarterly.

4. Each Certificate of Exportability request must be submitted
by a U.S. manufacturer only, whose name must appear on the
certificate.
5. The requestor should provide the owner operator number for
the registered manufacturer that he represents.

13. Issuance of a “Certificate of Exportability” will not preclude
regulatory action by FDA, if warranted, against products covered
by the Certificate.
14. If you have any questions, please call 301 796-7400, option 3,
or email [email protected].

6. All contract manufacturers and contract sterilizers involved in the
manufacturing process must be identified on the form regardless
if they are to appear on the certificate.

FORM FDA 3613a (4/24)

Page 9 of 10

Department of Health and Human Services
Food and Drug Administration

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

4. Requests for certificates should be sent to:

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.

5. The fee for preparing and issuing a single certificate for animal
drugs 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.

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)

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 3613a (4/24)

Page 10 of 10