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. Certificate for Devices Not Exported from the US
By: Nikita Angane
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 authorizationsuchasa 510(k),PMA, DeNovo,orHDEwithintheUS,and areidentical
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.
1 FDA (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