Nov 20, 2020

The US FDA published information on a new form of certification known as the Certificate for Device Not Exported from the United States (CDNE). The basis for issuing the CDNE is found in changes to section 801(e)(4)(E)(iii) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) made as part of the Coronavirus Aid, Relief, and Economic Security (CARES) Act. The CDNE is designed for medical devices that are manufactured outside the United States (and are therefore ineligible for standard export certificates) and shipped to another non-US country.

Eligibility criteria for requesting a CDNE from the FDA

In order to be eligible for a CDNE, medical devices must be authorized to be marketed in the US; the requirements state that they must be:

…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 request a CDNE must have been inspected by the FDA within the last three years or audited according to a program that the Agency recognizes or participates in. Results of such an audit must have been provided to the FDA within the last three years.

Submission and verification of CDNE requests

CDNE applications may be submitted using the CDRH Export Certification Application and Tracking System (CECATS); detailed submission instructions and information on fees can be found on the FDA’s resource page on CDNEs. The FAQ page on exporting medical devices also addresses CDNEs. The CDRH Export Certificate Validation (CECV) database may be used to verify CDNE issuance.

Learn more about US FDA medical device regulations at Emergo by UL:

  • Obtaining a CFG from the US FDA
  • FDA submission support for medical devices and IVDs
  • Whitepaper: Medical device testing requirements for FDA 510(k) submissions
  • Whitepaper: Early communication with the US FDA

Author

  • Timothy Herr

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