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  6. Devices Not Exported From the United States
  1. Exporting Medical Devices

Devices Not Exported From the United States

Overview

Revisions to section 801(e)(4)(E)(iii) of the FD&C Act as part of the Coronavirus Aid, Relief, and Economic Security (CARES) Act direct FDA to provide certification for devices that are not exported from the United States. Manufacturers of devices not exported from the United States, as described in section 801(e)(4)(E)(iii) of the FD&C Act, may not receive export certificates (e.g., CFG),  but may request a Certificate for Device Not Exported from the United States (CDNE).

Certificate for Device Not Exported from the United States

A Certificate for Device Not Exported from the United States (CDNE) may be issued for medical devices manufactured outside of the United States that are cleared, approved, granted a De Novo or subject of an approved humanitarian device exemption, on the market prior to May 28, 1976 or exempt from section 510(k) of the FD&C Act, but are not exported from the United States and are identical to the FDA authorized device with no modifications to the technology, intended use, indications for use or labeling.

Establishments that wish to request a CDNE must have been inspected by the FDA within 3 years of the date of the request, or audited pursuant to an FDA-recognized program or a program in which the FDA participates and the findings of such audit have been provided to the FDA within 3 years from the date of the request. (See section (801(e)(4)(E)(iii)(II)(aa) and (bb) of the FD&C Act).

As part of its request for a CDNE, an establishment certifies that:

  • The facility that appears on the certificate is currently registered with FDA under section 510 of the FD&C Act.
  • Each device is authorized to be marketed within the United States and:
    • is the subject of a premarket notification under section 510(k) of the Federal Food, Drug, & Cosmetic Act (FD&C Act); or
    • is the subject of an approved premarket approval application under section 515(d) of the FD&C Act; or
    • is the subject of an approved humanitarian device exemption under section 520(m) of the FD&C Act; or
    • has been granted De Novo request under section 513(f)(2) of the FD&C Act; or
    • was in commercial distribution before May 28,1976; or
    • is exempt from section 510(k) of the FD&C Act, subject to the limitations of exemption;
  • Each device identified is identical to the device as indicated above, and there have been no modifications to the technology, intended use, indications for use, or labeling;
  • The requesting establishment (a) has been inspected by the FDA within 3 years of the date of the request or (b) audited pursuant to an FDA-recognized program or a program in which the FDA participates and the findings of such audit have been provided to the FDA within 3 years from the date of the request; and
  • Each device identified is not exported from the United States.

How to Request a CDNE

The CDRH Export Certification Application and Tracking System (CECATS) is a web-based application system which can be used for requesting a CDNE. This system offers several benefits, including a reduction in certificate processing time, real-time validation of firm specific data, and status updates of the request. Using CECATS, users can make changes to an application prior to FDA review, upload additional documents such as mailing labels, and clone (auto populate) previously submitted application information for future requests using the "clone" icon.

To submit a request using CECATS:

  • Sign into your CECATS account using your account ID and password. CECATS may be accessed after logging into the FDA Unified Registration and Listing Systems (FURLS) using the establishment's FURLS account ID and password. See Accessing CECATS and Creating a Subaccount for additional instructions on how to access the system or set up a subaccount.
  • After you respond No to the question "Will the devices be exported from the United States?", you will be automatically directed to the CDNE application.

You will need the following information to submit a CDNE request.

  • Registration or owner/operator number for manufacturer.
  • Product code and marketing status with approval or cleared date for each device.
  • Device list.
  • Return shipping label (FedEx Express, UPS or DHL, self-addressed). The FDA cannot accept FedEx Home or Ground labels.

CDNE requestors must sign a Shipper's Certification Statement for devices not exported from the United States indicating compliance with applicable requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Detailed instructions are available while in CECATS by clicking on the question mark symbol on the page. Instructions can also be accessed on the CECATS Help Documentation web page.

If you have any questions regarding using CECATS, email [email protected] or call 301-796-7400 and select option 3.

For more information about CECATS, refer to the Exporting Medical Devices Frequently Asked Questions page.

Paper Application or Notification

Effective October 1, 2016, upon receipt of a paper application or notification, requestors will be contacted to submit their request using CECATS.

If you have question, contact CDRH Exports Team at [email protected] or call 301-796-7400 and select option 3.

Shipping Label

You are required to provide a prepaid FedEx Express, UPS, or DHL self-addressed label for the FDA to mail your certificates or permit to you once they are printed. FEDEX Ground or FEDEX Home labels are not accepted. The label should be unique for each application.

Fees

Section 801(e)(4)(B) of the FD&C Act authorizes the FDA to charge a fee for each certification that is issued within 20 working days.

The fee for each certificate issued by the FDA is $175.00 for the first certificate and $85.00 for each subsequent certificate from the same request. Certificates are provided on anti-counterfeit paper with an embossed gold seal.

Each certificate is limited to 25 pages (including the certificate, the manufacturer's page and the product attachment pages). There is no limit to the number of copies of each certificate that can be requested. However, $175 will be assessed per 25-page increment. When calculating the number of original certificates, fractions are rounded up to the next whole number.

For example: a request for 8 copies of a 10-page certificate will cost $1040 (10 pages x 8 copies = 80 pages); (80 pages / 25 = 3.2 or 4 original certificates); [($175 x 4 originals = $700) + ($85 x 4 additional certificates = $340)] = $1040.

The FDA will invoice quarterly for all certificates issued during that quarter.

CDRH Export Certificate Validation (CECV)

You can use the CECV database, which is updated once a week, to verify certificates issued by CDRH. The results displayed include the facility establishment name, certificate type, expiration date, certificate number, and the number of pages per certificate.

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