Form Approved: OMB No. 0910-0498; Expiration Date: 3/31/09

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| e |             |         |   |    |      |   |                        |   |
| s |             |         |   |    |      |   |                        |   |
| t |             |         |   |    |      |   |                        |   |
| i |             |         |   |    |      |   |                        |   |
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| g |             |         |   |    |      |   |                        |   |
| > |             |         |   |    |      |   |                        |   |
|   |             |         |   |    |      |   |                        |   |
| e |             |         |   |    |      |   |                        |   |
| x |             |         |   |    |      |   |                        |   |
| p |             |         |   |    |      |   |                        |   |
| o |             |         |   |    |      |   |                        |   |
| r |             |         |   |    |      |   |                        |   |
| t |             |         |   |    |      |   |                        |   |
| > |             |         |   |    |      |   |                        |   |
|   |             |         |   |    |      |   |                        |   |
| c |             |         |   |    |      |   |                        |   |
| e |             |         |   |    |      |   |                        |   |
| r |             |         |   |    |      |   |                        |   |
| t |             |         |   |    |      |   |                        |   |
| i |             |         |   |    |      |   |                        |   |
| f |             |         |   |    |      |   |                        |   |
| i |             |         |   |    |      |   |                        |   |
| c |             |         |   |    |      |   |                        |   |
| a |             |         |   |    |      |   |                        |   |
| t |             |         |   |    |      |   |                        |   |
| e |             |         |   |    |      |   |                        |   |
| s |             |         |   |    |      |   |                        |   |
| . |             |         |   |    |      |   |                        |   |
+---+-------------+---------+---+----+------+---+------------------------+---+
|   | ***CBER     |         |   |    | ***  |   |                        |   |
|   | i           |         |   |    | CDRH |   |                        |   |
|   | nstructions |         |   |    | inst |   |                        |   |
|   | begin on    |         |   |    | ruct |   |                        |   |
|   | page 5.***  |         |   |    | ions |   |                        |   |
|   |             |         |   |    | for  |   |                        |   |
|   |             |         |   |    | 802  |   |                        |   |
|   |             |         |   |    | b    |   |                        |   |
|   |             |         |   |    | egin |   |                        |   |
|   |             |         |   |    | on   |   |                        |   |
|   |             |         |   |    | page |   |                        |   |
|   |             |         |   |    | 9    |   |                        |   |
|   |             |         |   |    | .*** |   |                        |   |
+---+-------------+---------+---+----+------+---+------------------------+---+
|   | ***CDRH     |         |   |    | **   |   |                        |   |
|   | i           |         |   |    | *CVM |   |                        |   |
|   | nstructions |         |   |    | inst |   |                        |   |
|   | for         |         |   |    | ruct |   |                        |   |
|   | 801(e)(1)   |         |   |    | ions |   |                        |   |
|   | begin on    |         |   |    | b    |   |                        |   |
|   | page 6.***  |         |   |    | egin |   |                        |   |
|   |             |         |   |    | on   |   |                        |   |
|   |             |         |   |    | page |   |                        |   |
|   |             |         |   |    | 13   |   |                        |   |
|   |             |         |   |    | .*** |   |                        |   |
+---+-------------+---------+---+----+------+---+------------------------+---+

+--------------------------+-----------------------+------------------+
| Department of Health and | **EXPORTER'S          |                  |
| Human Services\          | CERTIFICATION         |                  |
| Food and Drug            | STATEMENT**           |                  |
| Administration           |                       |                  |
|                          | ***"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                |                       | 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 (9/06)  |                       |                  |
| Page 2 of 15**           |                       |                  |
+--------------------------+-----------------------+------------------+

+--------------------------+-----------------------+------------------+
| Department of Health and | #                     |                  |
| Human Services\          | ####### EXPORTER'S CE |                  |
| Food and Drug            | RTIFICATION STATEMENT |                  |
| Administration           |                       |                  |
|                          | ***"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  |                       |                  |
| regulations 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).    |                       |                  |
| >                        |                       |                  |
| > 5\. No HIV products    |                       |                  |
| > are listed on this     |                       |                  |
| > request.               |                       |                  |
| >                        |                       |                  |
| > 6\. No Class III       |                       |                  |
| > 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 (9/06)  |                       |                  |
| Page 3 of 15**           |                       |                  |
+--------------------------+-----------------------+------------------+

+--------------------------+-------+---------------+------------------+
| Department of Health and | **    |               |                  |
| Human Services\          | EXPOR |               |                  |
| Food and Drug            | TER'S |               |                  |
| Administration           | CER   |               |                  |
|                          | TIFIC |               |                  |
|                          | ATION |               |                  |
|                          | S     |               |                  |
|                          | TATEM |               |                  |
|                          | ENT** |               |                  |
|                          |       |               |                  |
|                          | ***"C |               |                  |
|                          | ERTIF |               |                  |
|                          | ICATE |               |                  |
|                          | OF    |               |                  |
|                          | EX    |               |                  |
|                          | PORTA |               |                  |
|                          | BILIT |               |                  |
|                          | Y"*** |               |                  |
|                          |       |               |                  |
|                          | *     |               |                  |
|                          | **for |               |                  |
|                          | CDRH  |               |                  |
|                          | (Se   |               |                  |
|                          | ction |               |                  |
|                          | 80    |               |                  |
|                          | 2)*** |               |                  |
+--------------------------+-------+---------------+------------------+
| ##                       |       |               |                  |
| ##### REQUESTING COMPANY |       |               |                  |
|                          |       |               |                  |
|                          |       |               |                  |
+--------------------------+-------+---------------+------------------+
| > As the responsible     |       | > 6\. Each    |                  |
| > official or designee   |       | > product(s)  |                  |
| > of the requesting      |       | > identified  |                  |
| > company named above, I |       | > for export  |                  |
| > hereby certify to the  |       | > accords to  |                  |
| > Food and Drug          |       | > the         |                  |
| > Administration (FDA)   |       | >             |                  |
| > that the company and   |       | specification |                  |
| > the products           |       | > of the      |                  |
| > identified on the      |       | > foreign     |                  |
| > attached application   |       | > purchaser;  |                  |
| > for a Certificate of   |       | > 801(e)(1);  |                  |
| > Exportability (Section |       | >             |                  |
| > 802) are to the best   |       | > 7\. Each    |                  |
| > of my knowledge in     |       | > product(s)  |                  |
| > compliance with        |       | > identified  |                  |
| > Section 802 of the     |       | > is not      |                  |
| > Federal Food, Drug,    |       | > conflict    |                  |
| > and Cosmetic Act (the  |       | > with the    |                  |
| > Act) and all           |       | > laws of the |                  |
| > applicable or          |       | > country to  |                  |
| > pertinent regulations  |       | > which it is |                  |
| > enforced by the FDA as |       | > intended    |                  |
| > follows:               |       | > for export; |                  |
| >                        |       | > 801(e)(1);  |                  |
| > 1\. Requesting company |       | >             |                  |
| > is currently           |       | > 8\. The     |                  |
| > registered and has     |       | > shipping    |                  |
| > listed each of its     |       | > package for |                  |
| > medical devices        |       | > the         |                  |
| > identified for export  |       | > product(s)  |                  |
| > as required by Section |       | > is labeled  |                  |
| > 510 of the Act and 21  |       | > on the      |                  |
| > CFR Part 807 (see      |       | > outside     |                  |
| > attached Supplementary |       | > that it is  |                  |
| > Information);          |       | > intended    |                  |
| >                        |       | > for export; |                  |
| > 2\. Each product(s)    |       | > 801(e)(1);  |                  |
| > identified for export  |       | >             |                  |
| > is manufactured        |       | > 9\. The     |                  |
| > substantially in       |       | > product(s)  |                  |
| > accordance with good   |       | > is not sold |                  |
| > manufacturing          |       | > or offered  |                  |
| > practices or           |       | > for sale in |                  |
| > international quality  |       | > domestic    |                  |
| > systems standards      |       | > commerce    |                  |
| > recognized by the      |       | > (the United |                  |
| > Secretary; 802(f)(1)   |       | > States);    |                  |
| > (At this time, the     |       | > and         |                  |
| > Secretary has not      |       | > 801(e)(1);  |                  |
| > recognized any         |       | >             |                  |
| > international quality  |       | > 10\. The    |                  |
| > system standards,);    |       | > product(s)  |                  |
| >                        |       | > identified  |                  |
| > 3\. Each product(s)    |       | > is not an   |                  |
| > identified is not      |       | > imminent    |                  |
| > adulterated by         |       | > hazard to   |                  |
| > containing any filthy, |       | > health in   |                  |
| > putrid or decomposed   |       | > the United  |                  |
| > substance in whole or  |       | > States, as  |                  |
| > in part; 501(a)(1);    |       | > notified by |                  |
| >                        |       | > the         |                  |
| > 4\. Each product(s)    |       | > Secretary;  |                  |
| > identified is not      |       | >             |                  |
| > prepared, packed or    |       | 802(f)(4)(B); |                  |
| > held under insanitary  |       | > and         |                  |
| > conditions whereby it  |       | >             |                  |
| > may be contaminated    |       | > 11\. The    |                  |
| > with filth or rendered |       | > product(s)  |                  |
| > injurious to health;   |       | > identified  |                  |
| > 501(a)(2)(A);          |       | > are labeled |                  |
| >                        |       | > in          |                  |
| > 5\. Each product(s)    |       | > accordance  |                  |
| > container does not     |       | > with the    |                  |
| > contain any poisonous  |       | >             |                  |
| > or deleterious         |       |  requirements |                  |
| > substance which may    |       | > of the Tier |                  |
| > render the device      |       | > 1 Country   |                  |
| > injurious to health;   |       | > (country    |                  |
| > 501(a)(3);             |       | > granting    |                  |
|                          |       | > valid       |                  |
|                          |       | > marketing   |                  |
|                          |       | >             |                  |
|                          |       | authorization |                  |
|                          |       | > under       |                  |
|                          |       | > 802(b))     |                  |
|                          |       | > that        |                  |
|                          |       | > granted     |                  |
|                          |       | > marketing   |                  |
|                          |       | > a           |                  |
|                          |       | uthorization, |                  |
|                          |       | > 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);  |                  |
|                          |       | >             |                  |
|                          |       | > 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 (9/06)  |       |               |                  |
| Page 4 of 15**           |       |               |                  |
+--------------------------+-------+---------------+------------------+

**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]{.underline})***

**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 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 301-827-6201.

• 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.**

+-----------------------------------+-----------------------------------+
| **Department of Health and Human  |                                   |
| Services\                         |                                   |
| Food and Drug Administration**    |                                   |
|                                   |                                   |
| **INSTRUCTIONS FOR REQUESTS FOR** |                                   |
|                                   |                                   |
| **CERTIFICATE OF EXPORTABILITY    |                                   |
| \[Section 801(e)(1)\]**           |                                   |
|                                   |                                   |
| ***(for [CDRH]{.underline})***    |                                   |
+-----------------------------------+-----------------------------------+
| > 1\. Complete the "Exporter's    | 7\. Clearly mark on the outside   |
| > Certification Statement" and    | of the envelope containing the    |
| > the "Supplementary Information  | request as a "Request for         |
| > Sheet." Please ensure that you  | Certificates." If you have any    |
| > sign the Exporter's             | questions, please call 240        |
| > Certification Statement.        | 276-0132.                         |
| >                                 |                                   |
| > 2\. Using the attached example  | 8\. We do not certify Foreign     |
| > **(Attachment D)**, prepare on  | Manufacturers; therefore, please  |
| > plain white 8 ½" x 11" bond     | provide the name and address of   |
| > paper, the Certificate of       | the U.S. Initial Distributor      |
| > Exportability \[Section         | **(P.O. Box not acceptable)**.    |
| > 801(e)(1)\] **(print margin one |                                   |
| > inch, top margin one inch, 44   | 9\. As of March 1, 2003, CDRH has |
| > lines per page)**. You may also | the authority to charge \$175 for |
| > submit this information on a    | the first certificate and \$15    |
| > standard IBM compatible 3 ½"    | for any subsequent certificates   |
| > diskette using Word Perfect 5.1 | issued for the same product(s) in |
| > or Microsoft Word software.     | response to the same request.     |
| > Diskettes received will be      | **Please do not submit a check    |
| > scanned for viruses using an    | with your request, as FDA will    |
| > anti-virus scanning program. In | bill you quarterly.**             |
| > addition, diskettes submitted   |                                   |
| > will not be returned.           | 10\. If information is omitted in |
| >                                 | the application by the requester  |
| > 3\. If more than three products | or if clarification is needed on  |
| > to be included on the           | the supplied information, the     |
| > Certificate, provide a typed    | requester will be contacted via   |
| > list of products on             | email, telephone, or FAX. If the  |
| > consecutively numbered 8 ½" x   | requester does not provide the    |
| > 11" sheets of paper             | necessary information within 48   |
| > **(Attachment E)**. Do not      | hours, the request for            |
| > submit catalogs or catalog      | certificates will be returned and |
| > pages.                          | will need to be resubmitted for   |
| >                                 | FDA review.                       |
| > 4\. Effective July 1, 1999,     |                                   |
| > each request is limited to a    | 11\. Issuance of a "Certificate   |
| > total of 100 pages, including   | to Foreign Government" or         |
| > the Certificate and Attachment  | "Certificate of Exportability"    |
| > Page(s). If your need exceeds   | will not preclude regulatory      |
| > the 100 page limit, you must    | action by FDA, if warranted,      |
| > request additional              | against products covered by the   |
| > certificates. For example, if   | Certificate.                      |
| > you request a certificate with  |                                   |
| > 9 attachment pages (for a total | 12\. A "Certificate to Foreign    |
| > of 10 pages), you may request   | Government" or "Certificate of    |
| > up to 1 original and 9          | Exportability" is issued by FDA   |
| > subsequent certificates.        | solely for export purposes and    |
| >                                 | may not be used for domestic      |
| > 5\. Enclose a self-addressed    | advertising.                      |
| > 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              |                                   |
| >                                 |                                   |
| > 9200 Corporate Boulevard        |                                   |
| >                                 |                                   |
| > Rockville, MD 20850             |                                   |
+-----------------------------------+-----------------------------------+
|                                   |                                   |
+-----------------------------------+-----------------------------------+
| **FORM FDA 3613a (9/06) Page 7 of |                                   |
| 15**                              |                                   |
+-----------------------------------+-----------------------------------+

+----------------------------------+----------------------------------+---+
| > **[instructions for Requests   |                                  |   |
| > for Certificate of             |                                  |   |
| > Exportability \[Section        |                                  |   |
| > 801(e)(1)\] (for CDRH)         |                                  |   |
| > *(Continued)*]{.underline}**   |                                  |   |
|                                  |                                  |   |
| ***ATTACHMENT D***               |                                  |   |
|                                  |                                  |   |
| ######### E X A M P L E          |                                  |   |
|                                  |                                  |   |
| > 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) NAME OF   |                                  |   |
| > COMPANY, ADDRESS**             |                                  |   |
| >                                |                                  |   |
| > **(GENERIC NAME IF             |                                  |   |
| > APPLICABLE)**                  |                                  |   |
| >                                |                                  |   |
| > 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 year.     |                                  |   |
| >                                |                                  |   |
| > *Signature*                    |                                  |   |
+----------------------------------+----------------------------------+---+
| > **[instructions for Requests   |                                  |   |
| > for Certificate of             |                                  |   |
| > Exportability \[Section        |                                  |   |
| > 801(e)(1)\] (for CDRH)         |                                  |   |
| > *(Continued)*]{.underline}**   |                                  |   |
|                                  |                                  |   |
| ***ATTACHMENT E***               |                                  |   |
|                                  |                                  |   |
| #######                          |                                  |   |
| ## EXAMPLE OF ATTACHMENT PAGE(S) |                                  |   |
|                                  |                                  |   |
| ![](media/image1.                |                                  |   |
| png){width="7.638888888888889in" |                                  |   |
| height="7.5in"}                  |                                  |   |
+----------------------------------+----------------------------------+---+
| **Department of Health and Human |                                  |   |
| Services\                        |                                  |   |
| Food and Drug Administration**   |                                  |   |
|                                  |                                  |   |
| **INSTRUCTIONS FOR REQUESTS      |                                  |   |
| FOR**                            |                                  |   |
|                                  |                                  |   |
| **CERTIFICATE OF EXPORTABILITY   |                                  |   |
| (Section 802)**                  |                                  |   |
|                                  |                                  |   |
| ***(for [CDRH]{.underline})***   |                                  |   |
+----------------------------------+----------------------------------+---+
| > 1\. Complete the "Exporter's   | > 8\. We do certify Foreign      |   |
| > Certification Statement" and   | > Manufacturers, if they have    |   |
| > the "Supplementary Information | > been inspected by FDA, and     |   |
| > Sheet." Please ensure that you | > this inspection was            |   |
| > sign the Exporter's            | > acceptable. Please provide the |   |
| > Certification Statement.       | > name and address of the U.S.   |   |
| >                                | > Initial Distributor **(P.O.    |   |
| > 2\. Using the attached example | > Box not acceptable),** for     |   |
| > **(Attachment F)**, prepare on | > billing purposes. Also, U.S.   |   |
| > plain white 8 ½" x 11" bond    | > Initial Distributor must be    |   |
| > paper, the Certificate of      | > listed on Certificate no       |   |
| > Exportability (Section 802)    | > exception.                     |   |
| > **(print margin one inch, top  | >                                |   |
| > margin one inch, 44 lines per  | > 9\. As of March 1, 2003, CDRH  |   |
| > page)**. You may also submit   | > has the authority to charge    |   |
| > this information on a CD or    | > \$175 for the first            |   |
| > disk using Microsoft Word or   | > certificate and \$15 for any   |   |
| > compatible software.           | > subsequent certificates issued |   |
| >                                | > for the same product(s) in     |   |
| > 3\. If more than three         | > response to the same request.  |   |
| > products to be included on the | > **Please do not submit a check |   |
| > Certificate, provide a typed   | > with your request, as FDA will |   |
| > list of products on            | > bill you quarterly.**          |   |
| > consecutively numbered 8 ½" x  | >                                |   |
| > 11" sheets of paper            | > 10\. The Certificate of        |   |
| > **(Attachment G)**. Do not     | > Exportability (Section 802)    |   |
| > submit catalogs or catalog     | > \[**Attachment F\]** may be    |   |
| > pages.                         | > copied and used for subsequent |   |
| >                                | > shipments, as long as an       |   |
| > 4\. Effective July 1, 1999,    | > original Foreign Country       |   |
| > each request is limited to a   | > Certification Statement        |   |
| > total of 100 pages, including  | > **(Attachment H)** is          |   |
| > the Certificate and the        | > attached. **Note:** FDA will   |   |
| > Attachment Page(s). If your    | > not authenticate copy of a     |   |
| > need exceeds the 100 page      | > certificate.                   |   |
| > limit, you must request        | >                                |   |
| > additional certificates. For   | > 11\. If information is omitted |   |
| > example, if you request a      | > in the application by the      |   |
| > certificate with 9 attachment  | > requester or if clarification  |   |
| > pages (for a total of 10       | > is needed on the supplied      |   |
| > pages), you may request up to  | > information, the requester     |   |
| > 1 original and 9 subsequent    | > will be contacted via email,   |   |
| > certificates **(10             | > telephone, or FAX. If the      |   |
| > Certificates)**.               | > requester does not provide the |   |
| >                                | > necessary information within   |   |
| > 5\. Enclose a self-addressed   | > 48 hours, the request for      |   |
| > stamped envelope or FEDEX      | > certificates will be returned  |   |
| > envelope large enough to       | > and will need to be            |   |
| > accommodate the requested      | > resubmitted for FDA review.    |   |
| > Certificate(s).                | >                                |   |
| >                                | > 12\. Issuance of a             |   |
| > 6\. Send the request and       | > "Certificate to Foreign        |   |
| > supporting documents to:       | > Government" or "Certificate of |   |
| >                                | > Exportability" will not        |   |
| > Food and Drug Administration   | > preclude regulatory action by  |   |
| >                                | > FDA, if warranted, against     |   |
| > Center for Devices and         | > products covered by the        |   |
| > Radiological Health            | > Certificate.                   |   |
| >                                | >                                |   |
| > Office of Compliance           | > 13\. A "Certificate to Foreign |   |
| >                                | > Government" or "Certificate of |   |
| > Attention: HFZ-307             | > Exportability" is issued by    |   |
| >                                | > FDA solely for export purposes |   |
| > 9200 Corporate Boulevard       | > and may not be used for        |   |
| >                                | > domestic advertising.          |   |
| > Rockville, MD 20850            |                                  |   |
| >                                |                                  |   |
| > 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     |                                  |   |
| > *exportcert@cdrh.fda.gov*.     |                                  |   |
+----------------------------------+----------------------------------+---+
|                                  |                                  |   |
+----------------------------------+----------------------------------+---+
| > **[instructions for Requests   |                                  |   |
| > for Certificate of             |                                  |   |
| > Exportability (Section 802)    |                                  |   |
| > (for CDRH)                     |                                  |   |
| > *(Continued)*]{.underline}**   |                                  |   |
|                                  |                                  |   |
| ***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 |                                  |   |
| > to Section 802 of the Act.     |                                  |   |
| >                                |                                  |   |
| > **NAME OF PRODUCT(S)           |                                  |   |
| > MANUFACTURING LOCATION**       |                                  |   |
| >                                |                                  |   |
| > **(GENERIC NAME IF             |                                  |   |
| > APPLICABLE)**                  |                                  |   |
| >                                |                                  |   |
| > 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 *Signature*  |                                  |   |
| >                                |                                  |   |
| > Subscribed and sworn to before |                                  |   |
| > me this day of month year.     |                                  |   |
|                                  |                                  |   |
| +-----------------------------+  |                                  |   |
| | > **[instructions for       |  |                                  |   |
| | > Requests for Certificate  |  |                                  |   |
| | > of Exportability (Section |  |                                  |   |
| | > 802) (for CDRH)           |  |                                  |   |
| | > *                         |  |                                  |   |
| | (Continued)*]{.underline}** |  |                                  |   |
| |                             |  |                                  |   |
| | ***ATTACHMENT G***          |  |                                  |   |
| |                             |  |                                  |   |
| | ######### EX                |  |                                  |   |
| | AMPLE OF ATTACHMENT PAGE(S) |  |                                  |   |
| |                             |  |                                  |   |
| | ![](media/image2.png){w     |  |                                  |   |
| | idth="7.6618055555555555in" |  |                                  |   |
| | he                          |  |                                  |   |
| | ight="7.551388888888889in"} |  |                                  |   |
| +-----------------------------+  |                                  |   |
|                                  |                                  |   |
| > **[instructions for Requests   |                                  |   |
| > for Certificate of             |                                  |   |
| > Exportability (Section 802)    |                                  |   |
| > (for CDRH)                     |                                  |   |
| > *(Continued)*]{.underline}**   |                                  |   |
|                                  |                                  |   |
| ***ATTACHMENT H***               |                                  |   |
|                                  |                                  |   |
| **FOREIGN COUNTRY CERTIFICATION  |                                  |   |
| STATEMENT**                      |                                  |   |
|                                  |                                  |   |
| > As a responsible official of   |                                  |   |
| > [     ]{.underline} , 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                      |                                  |   |
| >                                |                                  |   |
| > [     ]{.underline}            |                                  |   |
| >                                |                                  |   |
| > Typed Name and Title           |                                  |   |
| >                                |                                  |   |
| > Subscribed and sworn to before |                                  |   |
| > me this [    ]{.underline} day |                                  |   |
| > of month [    ]{.underline}    |                                  |   |
| > year.                          |                                  |   |
+----------------------------------+----------------------------------+---+

**Department of Health and Human Services**

**Food and Drug Administration**

**INSTRUCTIONS FOR COMPLETION OF**

**APPLICATION FOR CERTIFICATES**

***(for [CVM]{.underline})***

> 1\. The Export Certificate to Foreign Governments is for the export of
> products legally marketed in the United States. An applica-tion form
> must be completed and signed. The form is to be com-pleted by the
> responsible head or designee of the exporting firm. Please enclose
> labels for each product.
>
> 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 prod-uct 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 Infor-mation -- 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 en-closed with the certificate request.
>
> 4\. If the requested information on the application form is not
> pro-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 certifi-cates will be
> returned and will need to be resubmitted. You may enclose a completed
> FEDEX form to expedite return of the Cer-tificates. A certificate will
> be issued 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\
> (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/exportcertificate.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.**

**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 Certifi-cate. Certificates
issued by the FDA are solely for export pur-poses 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)

9200 Corporate Boulevard

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.*