Certificate for Devices Not Exported from the US

by | Nov 25, 2020 | Exports, FDA, Medical Devices, Quality, Regulatory

The US FDA introduced a new form of certificate referred to as the Certificate for Devices Not Exported from the US (CDNE). These certificates are for devices not manufactured in the US and hence are not eligible for export certificates that are described in our blog: FDA EXPORT CERTIFICATES

A CDNE is issued by the US FDA for devices manufactured outside of the US, have a valid marketing authorization such as a 510(k), PMA, De Novo, or HDE within the US, and are identical to the FDA authorized device with no modifications to the technology, intended use, indications for use, or labeling. Since these devices are manufactured outside of the US, they are not exported to non-US countries from the US.1

Regulatory authorities in some countries require these certificates to ensure that the devices have the appropriate authorization to market the product in the US. To request such a certificate, companies must have been inspected by the FDA within 3 years of the date of the request, or audited according to an FDA-recognized program with the audit findings provided to the FDA within 3 years from the date of the request.1

As part of its request for a CDNE, the manufacturers certify that:1

  • The facility on the certificate is registered with the FDA
  • The establishment has been inspected by the FDA within 3 years of the date of request
  • The device is subjected to a pre-market submission within the US or exempted as per the regulations
  • The device is identical to the one distributed within the US and
  • The device is not exported from the US

Manufacturers can submit a request for a CDNE through the CDRH Export Certification Application and Tracking System (CECATS), a web-based application system of the FDA. Each certificate costs $175, and $85 for each subsequent certificate from the same request.1

EMMA International can help in exporting your medical device. Call us today at +1 248-987-4497 or email us at info@emmainternational.com to know more about how we can help.


1FDA (Nov 2020) Devices Not Exported From the United States retrieved on 11/22/2020 from https://www.fda.gov/medical-devices/importing-and-exporting-medical-devices/devices-not-exported-united-states

 

Nikita Angane

Nikita Angane

Solutions Delivery Specialist - Ms. Angane is a Bioengineering graduate with experience in medical device commercialization, product development, quality system compliance and regulatory affairs. Her portfolio includes working on medical devices, combination products, and pharmaceuticals. As a Solutions Delivery Specialist at EMMA International, she offers her expertise to help our clients achieve an effective and sustainable quality system, and develop regulatory strategies for market access and compliance of new products in the US and international markets. Ms. Angane earned a Bachelor of Engineering in Biomedical Engineering from the University of Mumbai, India and an M.S. in Bioengineering from University of Illinois at Chicago.

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