FDA 3613g Certificate for Device Not Exported from the United Stat

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

CERTIFICATE 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 7

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 5 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 6 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
ADDRESS (P.O. Box not acceptable)

FIRM

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

4. INDICATE WHAT DEVICE INFORMATION SHOULD APPEAR ON THE CERTIFICATE.
5. INDICATE THE COUNTRY DESTINATION FOR WHICH THE CERTIFICATE(s) is requested. It will be listed on the certificate. CDNE
cannot be used to ship device(s) to the United States.
6. INDICATE THE TOTAL NUMBER OF CERTIFICATES REQUESTED:

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

"CERTIFICATE 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 facility named immediately above, I hereby certify to the
Food and Drug Administration (FDA) that:
1. Each facility that appears on the certificate is currently registered.
2.

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 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.
3.

Each device identified is identical to the device as indicated in number 2 above, and there have been no modifications to the technology,
intended use, indications for use, or labeling;

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

5.

Each device identified is not exported from 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 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 facility named immediately above, I hereby certify to the
Food and Drug Administration (FDA) that:
1. Each facility that appears on the certificate is currently registered;
2.

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 section 510(k) of the FD&C Act, subject to the limitations of exemption.

3.

Each device identified is identical to the device as indicated in number 2 above, and there have been no modifications to the technology,
intended use, indications for use or labeling;

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

5.

There are no HIV devices listed on the certificate; and

6.

Each device(s) identified is not exported from the United States.

I hereby make this certification of compliance statement to FDA with full knowledge that the making or submission of false statements
represent violations of 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 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 for Device Not Exported from the United States (CDNE)
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 CDNE, the following requirements must be met:

7.

If requested, you will need to show proof that a device was
offered for sale prior to May 28, 1976.

8.

Request an CDNE 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. The requesting establishment must be in compliance with
the registration requirements;
b. 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) of the FD&C Act; or an approved Biologics
License Application under section 351 of the Public Health
Service Act.
c. The device name must appear on the CDNE as authorized
for marketing in the U.S.
d. 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.
f.

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. 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

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

2.

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

3.

Country of origin (manufacturer’s location) and country of
destination will be listed on the certificate.

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.

12. 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.

5.

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

13. Issuance of a CDNE will not preclude regulatory action by FDA,
if warranted, against products covered by the Certificate.

6.

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

14. 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 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 for Device Not Exported from the United States
(CDNE) 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 CDNE, the following requirements must be met:

8.

Request an CDNE 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.

a. The requesting establishment must be in compliance with
the registration requirements;

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.

b. 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) of the FD&C Act

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.

c. The device name must appear on the CDNE as authorized
for marketing in the U.S.
d. 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).
f.

11. 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:

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

2.

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

3.

Country of origin (manufacturer’s location) and country of
destination will be listed on the certificate.

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 facility must provide a signed
Shipper’s Certification Statement.

6.

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

7.

If requested, you will need to show proof that a device was
offered for sale prior to May 28, 1976.

Food and Drug Administration
CDRH-Office of Regulatory Programs
Exports Team
10903 New Hampshire Ave.
Building 66, Room 1423
Silver Spring, MD 20993-0002
12. CDRH has the authority to charge $175.00 for the first certificate
and $85.00 each for THE subsequent copies. To streamline
billing, invoices are sent at the end of the quarter during which the
application was received.
13. Issuance of a CDNE will not preclude regulatory action by FDA,
if warranted, against products covered by the Certificate.
14. If you have any questions, please call 301 796-7400, option 3, or
email [email protected].

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This section applies only to requirements of the Paperwork Reduction Act of 1995.
*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 one 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.”

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