Form FDA 3613a FDA 3613a Supplementary Information Certificate of Exportability R

Form Approved: OMB No. 0910-0498; Expiration Date: 2/28/06

SUPPLEMENTARY INFORMATION
CERTIFICATE OF EXPORTABILITY 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

2. Manufacturer Information
Firm

Address (P.O. Box not acceptable)

Registration number

Date of last FDA inspection

3. Product Information
Product name

Does the product have an approved IDE?
Yes

Product class

No

If yes, provide IDE number:
Class 1

Class 2

Class 3

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

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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 a specific country on a certificate.)
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 Exportabilit. Notification to FDA
is required when the exporter first begins to export and should be sent to the same address for requesting export certificates.

CBER instructions begin on page 5.

CDRH instructions for 802 begin on page 9.

CDRH instructions for 801(e)(1) begin on page 6.

CVM instructions begin on page 13.

FORM FDA 3613a (2/06)

Page 1 of 13

PSC Graphic Arts: (301) 443-1090

EF

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:
• the product(s) accords to the specifications of the foreign purchaser;
• the product(s) is not in conflict with the laws of the country to which it is intended for export;
• the shipping package for the product(s) is labeled on the outside that it is intended for export; and
• the product(s) is not sold or offered for sale in the United States
(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

NAME AND TITLE

DATE

OF
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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 (2/06)

Page 2 of 13

Department of Health and Human Services
Food and Drug Administration

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

REQUESTING COMPANY

As the responsible official or designee of the requesting company named above, I hereby certify to the Food and
Drug Administration (FDA) that the company and the products identified on the attached application for a Certificate of Exportability [Section 801(e)(1)] are to the best of my knowledge in compliance with [Section 801(e)(1)]
of the Federal Food, Drug, and Cosmetic Act (the Act) and all applicable or pertinent rgulations enforced by the
FDA as follows:
1. Each product(s) identified for export accord to the specification of the foreign purchaser; 801(e)(1);
2. Each product(s) identified are not in conflict with the laws of the country to which it is intended for export;
801(e)(1)
3. The product(s) shipping package for the product(s) is labeled on the outside that it is intended for export;
801(e)(1); and
4. The product(s) is not sold or offered for sale in domestic commerce (the United States); 801(e)(1).

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No Class III products are listed on this request. PR

5. No HIV products are listed on this request.
6.

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

FORM FDA 3613a (2/06)

Page 3 of 13

Department of Health and Human Services
Food and Drug Administration

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

REQUESTING COMPANY

As the responsible official or designee of the requesting company named above, I hereby certify to the Food and Drug Administration (FDA) that the company and the products identified on the attached application for a Certificate of
Exportability (Section 802) are to the best of my knowledge
in compliance with Section 802 of the Federal Food, Drug,
and Cosmetic Act (the Act) and all applicable or pertinent regulations enforced by the FDA as follows:

6. Each product(s) identified for export accords to the specification of the foreign purchaser; 801(e)(1);

(requesting company) is currently registered and 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);

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

1.

2. Each product(s) identified for export is manufactured
substantially in accordance with good manufacturing
practices or international quality systems standards recognized by the Secretary; 802(f)(1) (At this time, the
Secretary has not recognized any international quality
system standards,);
3.

7. Each product(s) identified is not conflict with the laws
of the country to which it is intended for export;
801(e)(1);
8. The shipping package for the product(s) is labeled on
the outside that it is intended for export; 801(e)(1);

10. The product(s) identified is not an imminent hazard to
health in the United States, as notified by the Secretary;
802(f)(4)(B); and
11. The product(s) identified are labeled in accordance with
the requirements of the Tier 1 Country (country granting valid marketing authorization under 802(b)) that
granted marketing authorization, 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);

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Each product(s) identified is not adulterated by contain-

ing any filthy, putrid or decomposed substance in whole
or in part; 501(a)(1);
4. 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);
5. Each product(s) container does not contain any poisonous or deleterious substance which may render the device injurious to health; 501(a)(3);

12. The product(s) identified is promoted in accordance with
labeling requirement of 802(f)(5); 802(f)(6).
13. No HIV products are listed on this request.
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

FORM FDA 3613a (2/06)

Page 4 of 13

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.

ponent 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 Cosemetic 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.

OF
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PR • If information is omitted in the application by the requester or if
• The “Certificate to Foreign Government” is for the export of
General Instructions:

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 com-

FORM FDA 3613a (2/06)

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 301-594-0940
• 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.

Page 5 of 13

Department of Health and Human Services
Food and Drug Administration

INSTRUCTIONS FOR REQUESTS FOR
CERTIFICATE OF EXPORTABILITY [Section 801(e)(1)]
(for CDRH)
1. Complete the “Exporter’s Certification Statement” and the
“Supplementary Information Sheet.” Please ensure that you sign
the Exporter’s Certification Statement.

7. Clearly mark on the outside of the envelope containing the request as a “Request for Certificates.” If you have any questions,
please call 240 276-0132.

2. Using the attached example (Attachment D), prepare on plain
white 8 ½” x 11” bond paper, the Certificate of Exportability
[Section 801(e)(1)] (print margin one inch, top margin one
inch, 44 lines per page). You may also submit this information
on a standard IBM compatible 3 ½” diskette using Word Perfect
5.1 or Microsoft Word software. Diskettes received will be
scanned for viruses using an anti-virus scanning program. In
addition, diskettes submitted will not be returned.

8. We do not certify Foreign Manufacturers; therefore, please provide the name and address of the U.S. Initial Distributor (P.O.
Box not acceptable).

3.

9. As of March 1, 2003, CDRH has the authority to charge $175
for the first certificate and $15 for any subsequent certificates
issued for the same product(s) in response to the same request.
Please do not submit a check with your request, as FDA will
bill you quarterly.

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If more than three products to be included on the Certificate,
provide a typed list of products on consecutively numbered 8
½” x 11” sheets of paper (Attachment E). Do not submit catalogs or catalog pages.

4. Effective July 1, 1999, each request is limited to a total of 100
pages, including the Certificate and Attachment Page(s). If your
need exceeds the 100 page limit, you must request additional
certificates. For example, if you request a certificate with 9 attachment pages (for a total of 10 pages), you may request up to
1 original and 9 subsequent certificates.
5. Enclose a self-addressed stamped envelope or FEDEX envelope large enough to accommodate the requested Certificate(s).

10. 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 email, 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.
11. Issuance of a “Certificate to Foreign Government” or “Certificate of Exportability” will not preclude regulatory action by
FDA, if warranted, against products covered by the Certificate.
12. A “Certificate to Foreign Government” or “Certificate of
Exportability” is issued by FDA solely for export purposes and
may not be used for domestic advertising.

6. Send the request and supporting documents to:
Food and Drug Administration
Center for Devices and Radiological Health
Office of Compliance
Attention: HFZ-307
2094 Gaither Road
Rockville, MD 20850
FORM FDA 3613a (2/06)

Page 6 of 13

instructions for Requests for Certificate of Exportability [Section 801(e)(1)] (for CDRH) (Continued)

ATTACHMENT D

EXAMPLE

Certificate No.

CERTIFICATE OF EXPORTABILITY [SECTION 801(e)(1)]
The Food and Drug Administration certifies that the product(s) described below is subject to it jurisdiction
under the Federal Food, Drug, and Cosmetic Act (the Act). The products described below may not be sold or
offered for sale in the United States. The company has certified to the Food and Drug Administration that:
❖

the product(s) accords to the specifications of the foreign purchaser;

❖

the product(s) is not in conflict with the laws of the country to which it is intended for export;

❖

the shipping package for the product(s) is labeled on the outside that it is intended for export; and

❖

the product(s) is not sold or offered for sale in the United States.

Based on the information above, the product(s) listed below may be exported pursuant to Section 801(e)(1) of
the Act.
NAME OF PRODUCT(S)
(GENERIC NAME IF APPLICABLE)

F OF COMPANY, ADDRESS
ONAME
O
PR

Regulatory Policy and Systems Branch
Office of Compliance
Center for Devices and Radiological Health

This certificate expires 24 months
from the date notarized.
COUNTY OF MONTGOMERY
STATE OF MARYLAND
Subscribed and sworn to before me this

day of

month

Signature

FORM FDA 3613a (2/06)

Page 7 of 13

year.

instructions for Requests for Certificate of Exportability [Section 801(e)(1)] (for CDRH) (Continued)

ATTACHMENT E

EXAMPLE OF ATTACHMENT PAGE(S)

Certificate of Exportability [Section 801(e)(1)] – Attachment (Page # of # Pages)

List all
product(s)
separately
and state
associated
devices

Name of Product(s)
(Generic name if applicable)

Name of Manufacturer/
Distributor, Address

Arterial Fixation

ABC, Inc.
909 Glebe Road
Winter Haven, FL 33844

Mamary Prosthesis
Knee Cup
Penile Implant
Arterial Filter with air
separation chamber
Arterial Filter with Biothyl
coating

Please place
this statement at the
end of your
product

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“END OF PRODUCT LIST”

Paper Type: Plain White
8-1/2” x 11” Bond
Margins: Top
Left
Right
Bottom

1”
1”
1”
1”

Lower Right Corner 2-1/2” (to
allow for gold seal)

Gold
Seal

Note: Please list as many products
on each page as possible, minimum
Font size 9.

FORM FDA 3613a (2/06)

Page 8 of 13

Format should be
“Page # of Total
pages

Please list
company name
and address on
all attachment
pages

Department of Health and Human Services
Food and Drug Administration

INSTRUCTIONS FOR REQUESTS FOR
CERTIFICATE OF EXPORTABILITY (SECTION 802)
(for CDRH)
1. Complete the “Exporter’s Certification Statement” and the
“Supplementary Information Sheet.” Please ensure that you sign
the Exporter’s Certification Statement.
2. Using the attached example (Attachment F), prepare on plain
white 8 ½” x 11” bond paper, the Certificate of Exportability
(Section 802) (print margin one inch, top margin one inch,
44 lines per page). You may also submit this information on a
CD or disk using Microsoft Word or compatible software.
3. If more than three products to be included on the Certificate,
provide a typed list of products on consecutively numbered 8
½” x 11” sheets of paper (Attachment G). Do not submit catalogs or catalog pages.
4. Effective July 1, 1999, each request is limited to a total of 100
pages, including the Certificate and the Attachment Page(s). If
your need exceeds the 100 page limit, you must request additional certificates. For example, if you request a certificate with
9 attachment pages (for a total of 10 pages), you may request up
to 1 original and 9 subsequent certificates (10 Certificates).

8. We do certify Foreign Manufacturers, if they have been inspected
by FDA, and this inspection was acceptable. Please provide the
name and address of the U.S. Initial Distributor (P.O. Box not
acceptable), for billing purposes. Also, U.S. Initial Distributor
must be listed on Certificate no exception.
9. As of March 1, 2003, CDRH has the authority to charge $175
for the first certificate and $15 for any subsequent certificates
issued for the same product(s) in response to the same request.
Please do not submit a check with your request, as FDA will
bill you quarterly.
10. The Certificate of Exportability (Section 802) [Attachment F]
may be copied and used for subsequent shipments, as long as an
original Foreign Country Certification Statement (Attachment H) is attached. Note: FDA will not authenticate copy
of a certificate.

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PR 11. If information is omitted in the application by the requester or if

5. Enclose a self-addressed stamped envelope or FEDEX envelope large enough to accommodate the requested Certificate(s).
6. Send the request and supporting documents to:
Food and Drug Administration
Center for Devices and Radiological Health
Office of Compliance
Attention: HFZ-307
2094 Gaither Road
Rockville, MD 20850

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

7. Clearly mark on the outside of the envelope containing the request as a “Request for Certificates.” If you have any questions,
please call 240 276-0132 or email [email protected].
FORM FDA 3613a (2/06)

clarification is needed on the supplied information, the requester
will be contacted via email, 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.

13. A “Certificate to Foreign Government” or “Certificate of
Exportability” is issued by FDA solely for export purposes and
may not be used for domestic advertising.

Page 9 of 13

instructions for Requests for Certificate of Exportability (Section 802) (for CDRH) (Continued)

ATTACHMENT F

EXAMPLE

Certificate No.

CERTIFICATE OF EXPORTABILITY (SECTION 802)
The Food and Drug Administration certifies that the product(s) described below is subject to it jurisdiction
under the Federal Food, Drug, and Cosmetic Act (the Act). Such product(s), which is not approved for marketing in the United States, may be legally exported provided it meets the requirements of Section 802 of the Act.
Under Section 802 of the Act, a drug or device not approved for marketing in the United States may be
exported if it is manufactured, processed, packaged, and held in substantial conformity with current good
manufacturing practice requirements. The manufacturing plant(s) in which the product(s) is produced is subject to periodic inspections. The last such inspection showed that the plant(s), at that time, appeared to be in
substantial compliance with current good manufacturing practice requirements for the product(s) listed below.
The company has certified to the Food and Drug Administration that:
❖

the product(s) accords to the specifications of the foreign purchaser;

❖

the product(s) is not in conflict with the laws of the country to which it is intended for export;

❖

the shipping package for the product(s) is labeled on the outside that it is intended for export; and

❖

the product(s) is not sold or offered for sale in the United States.

Based on the information above, the product(s) listed below may be exported pursuant Section 802 of the
Act.:
NAME OF PRODUCT(S)
(GENERIC NAME IF APPLICABLE)

NAME OF COMPANY, ADDRESS
OF
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PR

Regulatory Policy and Systems Branch
Office of Compliance
Center for Devices and Radiological Health

This certificate expires 24 months
from the date notarized.
COUNTY OF MONTGOMERY
STATE OF MARYLAND
Subscribed and sworn to before me this

FORM FDA 3613a (2/06)

Signature

day of

Page 10 of 13

month

year.

instructions for Requests for Certificate of Exportability (Section 802) (for CDRH) (Continued)

ATTACHMENT G

EXAMPLE OF ATTACHMENT PAGE(S)

Certificate of Exportability (Section 802) – Attachment (Page # of # Pages)

List all
product(s)
separately
and state
associated
devices

Name of Product(s)
(Generic name if applicable)

Name of Manufacturer/
Distributor, Address

Arterial Filter

DEF, Inc.
2 Mary Road
Highpoint, NC 28567

Air Separation Chamber
Heart Valves Model 202
Arterial Filter with air
separation chamber
Arterial Filter with air
separation chamber &
Biothyl coating

Please place
this statement at the
end of your
product list

“END OF PRODUCT LIST”

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Paper Type: Plain White
8-1/2” x 11” Bond
Margins: Top
Left
Right
Bottom

1”
1”
1”
1”

Lower Right Corner 2-1/2” (to
allow for gold seal)

Gold
Seal

Note: Please list as many products
on each page as possible, minimum
Font size 9.

FORM FDA 3613a (2/06)

Page 11 of 13

Format should be
“Page # of Total
pages”

Please list
company name
and address on
all attachment
pages

instructions for Requests for Certificate of Exportability (Section 802) (for CDRH) (Continued)

ATTACHMENT H

FOREIGN COUNTRY CERTIFICATION STATEMENT

As a responsible official of
, I hereby certify that the
company and products identified in the attached Certificate of Exportability (Section 802) continue to be, to
the best of my knowledge, in compliance with the Federal Food, Drug, and Cosmetic Act and all applicable or
pertinent regulations enforced by the U.S. Food and Drug Administration. A Photocopy of the Certificate of
Exportability (Section 802) may be used as long as this original statement is attached..

Signature

Typed Name and Title

Subscribed and sworn to before me this

FORM FDA 3613a (2/06)

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Pday
of

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month

year.

Department of Health and Human Services
Food and Drug Administration

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

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

2. 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.
3. 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.
4.

(240-276-9212- for inquiries)
6. 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/export.certificate.htm).
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.

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If the requested information on the application form is not proPR
vided 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.

Paperwork Reduction Act Statement
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 applicable address below.
Food and Drug Administration
Center for Biologics Evaluation
and Research
1401 Rockville Pike
Rockville, MD 20857

Food and Drug Administration
Center for Devices and
Radiological Health (HFZ-307)
2094 Gaither Road
Rockville, MD 20850

Food and Drug Administration
Center for Veterinary Medicine (HFV-235)
Division of Compliance
7519 Standish Place
Rockville, MD 20855

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 3613a (2/06)

Page 13 of 13