FDA 3613c Supplementary Information Non-Clinical Research Use Only

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

Department of Health and Human Services
Food and Drug Administration

SUPPLEMENTARY INFORMATION
NON-CLINICAL RESEARCH USE ONLY CERTIFICATE

Send the Export Certificate Requests and supporting documents to the appropriate Center within FDA that would have
control over your product:
CBER: CBER regulates biological products, including blood and blood products, vaccines, allergenics, tissues, and
cellular and gene therapies. CBER also regulates the medical devices involved in the collection, processing, testing,
manufacture and administration of licensed blood, blood components and cellular products and all HIV test kits used
both to screen donor blood, blood components, and cellular products and to diagnose, treat, and monitor persons with
HIV and AIDS. Please see page 4 for CBER instructions on how to apply for this certificate.
CDRH: CDRH regulates devices ranging from thermometers to kidney dialysis machines and electronic products that
emit radiation such as microwaves. Please submit your application online using https://www.access.fda.gov/oaa.
Please see page 5 for CDRH instructions on how to apply for this certificate.

1A. Requestor Information
Name

Address

Firm

Telephone number

FAX number

Firm Tax ID code

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

Email address

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

Alternate Billing Email Address (if not the same as requestor)
2. Manufacturer Information
Firm

Address (P.O. Box not acceptable)

Registration number/Firm Establishment Identifier (FEI) (if applicable)

Center for Biologics Evaluation and Research (CBER)
instructions are on page 4.
FORM FDA 3613c (4/24)

Center for Devices and Radiological Health (CDRH)
instructions are on page 5.
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PSC Publishing Services (301) 443-6740

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3. List Product(s), Material(s), or Component(s) to be exported for non-clinical research use only.

4. List country(ies) for which the Certificates are requested. Please list at least 1 country.

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

No

FORM FDA 3613c (4/24)

Indicate the total number of certificates requested:
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Department of Health and Human Services
Food and Drug Administration

EXPORTER’S CERTIFICATION STATEMENT
“NON-CLINICAL RESEARCH USE ONLY CERTIFICATE”
for CBER and CDRH

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 these non-clinical research use product(s), material(s), or component(s) are to be used for nonclinical research use only. The product(s), material(s), or component(s) will not be used in the prevention, treatment, or
diagnosis of human disease. These non-clinical research use only materials will be labeled in accordance with 21 CFR
809.10(c)(2)(i) or 21 CFR 312.160, as appropriate, and exported as they are presently being sold or offered for sale in
the United States. I further certify that these non-clinical research use only materials will comply with the due diligence
requirements in 21 CFR 312.160, where applicable.
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 3613c (4/24)

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Department of Health and Human Services
Food and Drug Administration

EXPORT CERTIFICATION
Submission Requirements for Requesting Certificates for
Exporting Products to Foreign Countries (for CBER)
Background
Firms exporting products from the U.S. are often asked by foreign
customers or foreign governments to supply a certification relating
to products subject to the Federal Food, Drug, and Cosmetic Act
and other acts the Food and Drug Administration (FDA)
administers. Under the FDA Export Reform and Enhancement Act
of 1996 (the Act), FDA is authorized to issue certifications for
drugs, animal drugs, and devices within 20 days of receipt of a
request for such a certificate. A fee of up to $175 may be charged
for each export certification issued.

• Errors made by FDA during the preparation of export certificates
will be corrected, at no cost to the applicant, within 45 days after
issuance.
– Errors made in the application, by the requestor, cannot be
corrected. A new application must be submitted.
• Questions may be directed to the Import/Export Team at 240-4029155 or by email at [email protected].
• Send the request and supporting documents to
[email protected] or you can mail it to:

General Instructions:
• The “Non-clinical Research Use Only Certificate is an export
certification for 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.
• If information is omitted in the application by the requestor or if
clarification is needed on the supplied information, the requestor
will be contacted. If the requestor does not provide the necessary
information within 48 hours, the request for certificates will be
returned and will need to be resubmitted for FDA review.

FORM FDA 3613c (4/24)

Food and Drug Administration
Center for Biologics Evaluation and Research
Office of Compliance and Biologics Quality
Division of Case Management
10903 New Hampshire Ave.
Building 71, Room G112
Silver Spring, MD 20993-0002
• On October 1, 1996, CBER was given the authority to charge $175
for the first two certificates and $85 for any subsequent certificates
issued for the same product(s) in response to the same certificate
request. Please do not submit a check with your request, as FDA
will bill you quarterly for issued certificates.
• You may enclose a completed air billing number and mailing
supplies to expedite the return of Certificates.
Issuance of a “Certificate to Foreign Government”, “Certificate
of Exportability” or “Certificate of a Pharmaceutical Product”
will not preclude regulatory action by FDA, if warranted, against
products covered by the Certificate.

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Department of Health and Human Services
Food and Drug Administration

INSTRUCTIONS FOR NON-CLINICAL RESEARCH
USE ONLY CERTIFICATE (for CDRH)
1.

The “Non-Clinical Research Use Only” certificate is for
product(s), material(s), or component(s) that are not used to
prevent, treat, or diagnose human disease.

2.

The manufacturing facility is required to label these products
according to 21 CFR 809.10(c)(2)(i) or 21 CFR 312.160, as
appropriate.

3.

All products listed on Non-Clinical Research Use Only Certificate
must be exported from the U.S.

4.

Each Non-Clinical Research Use Only Certificate request must
be submittted by the U.S. manufacturer. Requests received from
a foreign firm will not be considered. A U.S. firm must appear
on each Non-Clinical Research Use Only Certificate.

5.

All contract manufacturers and contract sterilizers involved in
the manufacturing process must be identified on the 3613c form
regardless if they are to appear on the certificate.

6.

It is the requestor’s responsibility to ensure that the information
is supplied correctly, including spelling.

7.

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

FORM FDA 3613c (4/24)

8.

Request a Non Clinical Research Use Only Certificate using
our electronic system, the CDRH Export Certification
Application and Tracking System (CECATS) at https:/
www.access.fda.gov/oaa. If you have any problems, please
contact us at [email protected].

9.

If information is omitted in the application by the requestor or
if clarification is needed, the requestor will be contacted via
email or phone. If the requestor does not supply the necessary
information within 48 hours, the request for certificates will
be closed and will need to be resubmitted for FDA review.

10. Errors made by FDA during the preparation of export certificates
will be corrected, at no cost to the applicant, within 45 days after
issuance.
• Errors made in the application, by the submitter, cannot be
corrected. A new application must be submitted.
11. CDRH has the authority to charge $175.00 for the first certificate
and $85.00 each for the subsequent copies. The FDA will bill you
quarterly.
12. Issuance of a certificate will not preclude regulatory action by
FDA, if warranted, against products covered by the Certificate.
13. If you have any questions, please call 301-796-7400, option 3, or
email [email protected]

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FORM FDA 3613c (4/24)

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