FDA 3613g Certificate To Foreign Government For Device Not Exporte

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

CERTIFICATE TO FOREIGN GOVERNMENT
FOR DEVICE NOT EXPORTED FROM THE
UNITED STATES REQUESTS

Form Approved: OMB No. 0910-0498
Expiration Date: 4/30/2024
See PRA Statement on page 97

Supplementary Information
Submit certificate requests and supporting documents to the appropriate Center within FDA that would have control over your device:
CBER: CBER regulates devices involved in the collection, processing, testing, manufacture and administration of 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 65 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 86 for CDRH instructions on how to
apply for this certificate.

1A. REQUESTOR INFORMATION
NAME

ADDRESS

FIRM
OWNER OPERATOR NUMBER (if applicable)
TELEPHONE NUMBER

EMAIL ADDRESS

FIRM TAX ID NUMBER (Required for U.S. Requestor)

DUNS number (Required for Requestors outside of the U.S.)

1B. BILLING ADDRESS (if not the same as requestor)

1C. SHIPPING ACCOUNT NUMBER AND/OR LABEL
(Mailing supplies may be sent along with this form.)

ALTERNATE BILLING EMAIL ADDRESS (if not the same as requestor)

2. MANUFACTURER INFORMATION
FIRM

ADDRESS (P.O. Box not acceptable)

REGISTRATION NUMBER/FIRM ESTABLISHMENT IDENTIFIER (FEI)
LICENSE NUMBER (if applicable)

Date of last FDA inspection or MDSAP audit (must be within 3 years)

Center for Biologics Evaluation and Research (CBER) instructions begin on page 5.
Center for Devices and Radiological Health (CDRH) instructions are on page 6.

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3. DEVICE INFORMATION
TRADE NAME

PROPER NAME

MARKETING APPLICATION NUMBER (BLA/STN, De Novo,
HDE, PMA, 510(k), Preamendment or Exempt – Include number
and date approved/cleared/granted if applicable)

PRODUCT CODE and Import Entry Number

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:
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

"CERTIFICATE TO FOREIGN GOVERNMENT
FOR DEVICE NOT EXPORTED FROM THE
UNITED STATES" for CBER
Shipper’s Certification Statement
NAME OF MANUFACTURER
As a responsible official or designee authorized to represent and act on behalf of the facilityestablishment named immediately above, I hereby
certify to the Food and Drug Administration (FDA) that the establishment(s) and the device(s) identified in the Supplementary Information
Request are, to the best of my knowledge, in substantial compliance with the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and all
applicable or pertinent regulations, including the following:
1. Each facilityEach device that appears on the certificate is manufactured by a device establishment located outside of the United States.
1.2. Each establishment that appears on the certificate is currently registered underas required by section 510 of the FD&C Act.
3.

Each establishment has listed each of the devices that appear on the certificate, as required by Section 510(j) of the Act and 21 CFR Part 807
and 21 CFR Part 607;

2.4. Each device(s) identified herein is authorized to be marketed within the United States and:
a. is the subject of a premarket notification under section 510(k) of the Federal Food, Drug, & Cosmetic Act (FD&C Act);; or
b. is the subject of an approved premarket approval application under section 515(d) of the FD&C Act; or
c. is the subject of an approved humanitarian device exemption under section 520(m) of the FD&C Act; or
d. has been granted De novo request under section 513(f)(2) of the FD&C Act; or
e. was in commercial distribution before May 28,1976; or
f.

is exempt from not required to submit a premarket report pursuant to subsection (l) or (m) of section 510(k) of the FD&C Act, subject to
the limitations of exemption; or

g. is the subject of an approved Biologics License Application under section 351 of the Public Health Service Act.
5.

Each device(s) identified is identical to the device as indicated in number 2 above, and therenot subject to an open import alert, recall, seizure,
injunction, or the subject of any other open enforcement action initiated by FDA;

3.6. Manufacturers, contract manufacturers, and contract sterilizers involved in the manufacturing process, if applicable, have been no
modifications to the technology, intended use, indications for use, or labelingidentified in question 2 of this form;
4.

The requesting facility (a) has been inspected by FDA within the past 3 years of the date of this request or (b) audited pursuant to an FDArecognized program or a program in which FDA participates, and the findings of such audit have been provided to FDA within the past 3
years from the date of this request; and

7.

The requesting establishment and all establishments involved in the manufacturing process are operating in substantial compliance with
the Current Good Manufacturing Practices requirements (see 21 CFR Part 820 and/or the applicable requirements in 21 CFR Part 600680) for the identified device(s);

5.8. Each device identified is not exported fromimported or offered for import into the United States.
I hereby make this certification of compliance statement to FDA with full knowledge that the making or submitting of false statements on any
documents submitted to FDA may constitute violations of the United States Code Title 18, Chapter 47, Section 1001. Penalties include up to
$250,000 in fines and up to five years of imprisonment.
SIGNATURE

DATE

NAME AND TITLE

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

"CERTIFICATE TO FOREIGN GOVERNMENT
FOR DEVICE NOT EXPORTED FROM THE
UNITED STATES" for CDRH
Shipper’s Certification Statement
NAME OF MANUFACTURER
As a responsible official or designee authorized to represent and act on behalf of the facilityestablishment named immediately above, I hereby
certify to the Food and Drug Administration (FDA) that the establishment(s) and the device(s) identified in the Supplementary Information
Request are, to the best of my knowledge, in substantial compliance with the Federal Food, Drug, and Cosmetic Act (the Act) and all
applicable or pertinent regulations, including the following:
Each facility
1. Each device that appears on the certificate is manufactured by a device establishment located outside of the United States.
1.2. Each establishment that appears on the certificate is currently registered; under as required by Section 510 of the FD&C Act.
3. Each establishment has listed each of the devices that appear on the certificate as required by Section 510(j) of the FD&C Act and 21 CFR Part
807;
2.4. Each device(s) identified herein is authorized to be marketed within the United States and:
a. is the subject of a premarket notification under section 510(k) of the Federal Food, Drug, & Cosmetic Act (FD&C Act);; or
b. is the subject of an approved premarket approval application under section 515(d) of the FD&C Act; or
c. is the subject of an approved humanitarian device exemption under section 520(m) of the FD&C Act; or
d. has been granted De novo request under section 513(f)(2) of the FD&C Act; or
e. was in commercial distribution before May 28,1976; or
f.

5.

is exempt from not required to submit a premarket report pursuant to subsection (l) or (m) of section 510(k) of the FD&C Act, subject to
the limitations of exemption.

Each device(s) identified is identical to the device as indicated in number 2 abovenot subject to an open import alert, recall, seizure, injunction,
or the subject of any other open enforcement action initiated by FDA;

3.6. Manufacturers, contract manufacturers, and therecontract sterilizers involved in the manufacturing process, if applicable, have been no
modifications to the technology, intended use, indications for use or labelingidentified in question 2 of this form;
4.

The requesting facility (a) has been inspected by FDA within the past 3 years of the date of this request; or (b) audited pursuant to an
FDA-recognized program or a program in which FDA participates and the findings of such audit have been provided to FDA within the
past 3 years from the date of this request; and

7.

The requesting establishment and all establishments involved in the manufacturing process are operating in substantial compliance
with the Current Good Manufacturing Practices Regulationrequirements (21 CFR Part 820) for the identified device(s);
5.8. There are no HIV devices listed on the certificate; and
6.9. Each device(s) identified is not exported fromimported or offered for import into the United States.
I hereby make this certification of compliance statement to FDA with full knowledge that the making or submission of false statements
represent violations of the United States Code Title 18, Chapter 47, Section 1001. Penalties include up to $250,000 in fines and up to five
years of imprisonment.
SIGNATURE

DATE

NAME AND TITLE

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

INSTRUCTIONS FOR CERTIFICATE FORTO FOREIGN GOVERNMENT
FOR DEVICE NOT EXPORTED FROM THE UNITED STATES FOREIGN
GOVERNMENT (for CBER)
1.

Any medical device that may be legally marketed in the United
States (U.S.) may be shipped anywhere in the world without prior
Food and Drug Administration (FDA) notification or approval. The
Certificate Tto Foreign Government for Device Not Exported from
the United States (CDNECFG-NE) can be used for products that
have received marketing authorization by the FDA and will be
shipped from one foreign country to another without entering U.S.
commerce. To qualify for a CDNECFG-NE, the following
requirements must be met:
a. The device is manufactured by a device establishment
located outside of the United States;

5.

5.6.All contract manufacturers and contract sterilizers involved
in the manufacturing process must be identified on the
Supplementary Information Request regardless of whether they
are to appear on the certificate.
6.7. It is the requestor’s responsibility to ensure that the information
on the certificate is supplied correctly, including spelling.
7.8. If requested, you will need to show proof that a device was
offered for sale prior to May 28, 1976.

b. The requesting manufacturing establishment must be in
compliance with the registration requirements under
section 510 of the FD&C Act;

8.9. Request an CDNECFG-NE by sending the request and
supporting documents to:
Food and Drug Administration
Center for Biologics Evaluation and Research
Office of Compliance and Biologics Quality
Division of Case Management
10903 New Hampshire Ave.
Building 71, Room G112
Silver Spring, MD 20993-0002

a.c. The device is listed as required by Section 510(j) of the
Act and 21 CFR Part 807 and/or 21 CFR Part 607;
b.d. The device must have a cleared Premarket Notification
510(k) or Premarket Approval (PMA), or granted a De Novo
classification, or if the device was on the market prior to May
28, 1976 (before the Medical Device Amendments to the
FD&C Act), or approved humanitarian device exemption
under section 520(m) of the FD&C Act; or exempt from
section 510(k) ofis not required to submit a premarket report
pursuant to subsection (l) or (m) of section 510 of the FD&C
Act; or an approved Biologics License Application under
section 351 of the Public Health Service Act.
c.e. The device name must appear on the CDNECFG-NE as
authorized for marketing in the U.S.
d.f. The device must meet the labeling requirements of 21 CFR
Part 610, 21 CFR Part 660, 21 CFR Part 801, and 21 CFR
Part 809, if applicable;
e. The requesting establishment must meet the requirements
of section 801(e)(4)(E)(iii)(II) of the FD&C Act.
g. The device must be manufactured in accordance with the
Quality Systems (QS) Regulation or 21 CFR Part 820 and/or
the applicable requirements in 21 CFR Part 600-6806 (also
known as Current Good Manufacturing Practices or CGMP),
unless exempted by regulation

9.10. If information is omitted in the application by the requestor
or if clarification is needed, the requestor will be contacted via
email or phone. If the requestor does not supply the necessary
information within 48 hours, the request for certificates will be
closed and will need to be resubmitted for FDA review.
10.11. Errors made by FDA during the preparation of CFG-NEs
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.
11.12. Please include a return UPS or FedEx shipping label that
FDA can use to mail the certificates to you. The shipping label
must be trackable and electronically generated. When
creating the return shipping label, it must be addressed to
you. Please use the following as the sender’s address:
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

f.h. In addition, the requestor must comply with the laws of the
importing country.
2.

3.

4.

A representative of the requesting facilityestablishment must
provide a signed Shipper’s Certification Statement.

The CDNECFG-NE is limited to a Manufacturer. A Foreign
Distributor or Private Label Distributor does not qualify for a
CDNECFG-NE.

12.13. CBER has the authority to charge $175.00 for the first
certificate,
$175.00 for the first duplicate and $85.00 each for subsequent
copies. To streamline billing, invoices are sent at the end of the
quarter during which the application was received.

The certificate will list the country of origin
(manufacturer’s manufacturing establishment location)),
and will list the country of destination will be listed onif
requestor indicates it is required.. Otherwise, the
certificate. will indicate “foreign countries”.
The requestor should be a representative of the requesting
establishment by having an account associated with the Owner
Operator number of the requesting establishment.

13.14. Issuance of a CDNE CFG-NE willCertificate to Foreign
Government for Device not Exported from the United States
will not preclude regulatory action by FDA, if warranted, against
products covered by the Certificate.
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14.15. If you have any questions, please call the Import/Export
Team at 240-402- 9155 or by email at
[email protected].

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

INSTRUCTIONS FOR CERTIFICATE TO FOREIGN
GOVERNMENT FOR DEVICE NOT EXPORTED FROM
THE UNITED STATES (for CDRH)
1.

Any medical device that may be legally marketed in the United
States (U.S.) may be shipped anywhere in the world without prior
Food and Drug Administration (FDA) notification or approval. The
Certificate to Foreign Government for Device Not Exported from
the United States (CDNECFG-NE) can be used for products that
have received marketing authorization by the FDA and will be
shipped from one foreign country to another without entering U.S.
commerce. To qualify for a CDNECFG-NE, the following
requirements must be met:

provide a signed Shipper’s Certification Statement.
6.

6.7. It is the requestor’s responsibility to ensure that the information
on the certificate is supplied correctly, including spelling.
7.8. If requested, you will need to show proof that a device was
offered for sale prior to May 28, 1976.

a. The requestingdevice is manufactured by a device
establishment located outside of the United States;
a.b. The manufacturing establishment(s) must be in
compliance with the registration requirements under
section 510 of the FD&C Act;
c. The device is listed as required under section 510(j) of the
FD&C Act.
b.d. The device must have a cleared Premarket Notification
510(k) or Premarket Approval (PMA), or granted a De Novo
classification, or if the device was on the market prior to May
28, 1976 (before the Medical Device Amendments to the
FD&C Act); or approved humanitarian device exemption
under section 520(m) of the FD&C Act; or exempt from
section 510(k)is not required to submit a premarket report
pursuant to subsection (l) or (m) of section 510 of the FD&C
Act.
c.e. The device name must appear on the CDNECFG-NE as
authorized for marketing in the U.S.

8.9. Request an CDNEa CFG-NE using one of the following
methods:. To facilitate your request, please apply through 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 CDRHCECATS@fda. hhs.gov. You may
also mail the request, but effective October 1, 2016, requestors
will be contacted to submit requests through CECATS upon
receipt of a paper application or notification.
9.10. If information is omitted in the application by the requestor
or if clarification is needed, the requestor will be contacted via
email or phone. If the requestor does not supply the necessary
information within 48 hours, the request for certificates will be
closed and will need to be resubmitted for FDA review.
10.11. Errors made by FDA during the preparation of CFG-NEs
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.

d.f. The device must meet the labeling requirements of 21 CFR
Part 801 and 21 CFR Part 809, if applicable;
e. The requesting establishment must meet the requirements
of section 801(e)(4)(E)(iii)(II).
g. The device must be manufactured in accordance with the
Quality Systems (QS) Regulation or 21 CFR Part 820
(also known as Current Good Manufacturing Practices or
CGMP), unless exempted by regulation.

11.12. Please include a return UPS, or FedEx, or DHL label that
FDA can use to mail the certificates to you. The shipping label
must be trackable and electronically generated. When
creating the return shipping label, it must be addressed to
you. Please use the following as the sender’s address:
Food and Drug Administration
CDRH-Office of Regulatory Programs
Exports Team
10903 New Hampshire Ave.
Building 66, Room 1423
Silver Spring, MD 20993-0002

f.h. In addition, the requestor must comply with the laws of the
importing country.
2.

The CDNECFG-NE is limited to a Manufacturer. A Foreign
Distributor or Private Label Distributor does not qualify for a
CDNECFG-NE.

3.

The certificate will list the country of origin
(manufacturer’s manufacturing establishment location)),
and will list the country of destination will be listed on the
certificate.if requestor indicates it is required. Otherwise,
the certificate will indicate “foreign countries” as the
destination.

12.13. CDRH has the authority to charge $175.00 for the first
certificate and $85.00 each for theTHE subsequent copies. To
streamline billing, invoices are sent at the end of the quarter
during which the application was received.

4.

The requestor should be a representative of the requesting
establishment by having an account associated with the Owner
Operator number of the requesting establishment.

5.

A representative of the requesting facilityestablishment must

Form FDA 3613g (6/21) (PREVIOUS EDITION OBSOLETE)

All contract manufacturers and contract sterilizers involved in
the manufacturing process must be identified on the
Supplementary Information Request regardless of whether they
are to appear on the certificate.

13.14. Issuance of a CDNE CFG-NE”Certificate to Foreign
Government for Device Not Exported from the United States”
will not preclude regulatory action by FDA, if warranted, against
products covered by the Certificate.
14.15. If you have any questions, please call 301 796-7400, option
3, or email [email protected].
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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 1 hour per response, including the time to review instructions, search
existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding
this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Operations
Paperwork Reduction Act (PRA) Staff
[email protected]
“An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently
valid OMB control number.”

Form FDA 3613g (6/21) (PREVIOUS EDITION OBSOLETE)

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