Last month, the U.S. Food & Drug Administration (FDA) published online information on Certificate for Device Not Exported from the United States (CDNE). This is a new form of certification designed for Medical Devices manufactured outside the United States, therefore not suitable for standard export certificates and shipped to a non-US country.
The instructions for issuing the CDNE can be found in the amendments to section 801 (e) (4) (E) (iii) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Requirements for obtaining a Certificate for Devices not Exported from U.S.A.
A CDNE certificate may be issued for Medical Devices manufactured outside of the United States meeting the following requirements:
- a) they have been authorised, approved, provided according to procedure 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, b) not exported from the United States and c) identical to the FDA approved device without modifications to the technology, the intended use, indications for use or labelling;
- establishments requiring a CDNE must have been inspected by FDA within 3 years of the date of the request or audited in accordance with a programme recognised by FDA.
How to request the CDNE
The request to obtain the CDNE can be submitted using the CDRH Export Certification Application and Tracking System (CECATS), a system that offers several advantages including reduction of certificate processing time, real-time validation of company-specific data and status updates of the request.
For each certification issued, FDA is authorised to charge a commission. The fee for each certification issued by the FDA is $ 175,00 for the first certificate and $ 85,00 for each subsequent certificate from the same request.
After completion of the procedure, it is possible to use the CDRH Export Certificate Validation (CECV) database to verify the issuance of a CDNE certificate.
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