USA – US FDA introduces Certificate for Device Not Exported from the United States (CDNE)

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…