Regulatory Open Forum

Do we need an FDA Certificate of Exportability for exporting investigational IDE-exempt or non-significant risk IVDs into countries that are not on the Tier 1 List at § 802(b)(1)(A)?

Hello Anon,

In most cases yes, because if the product is not cleared or approved in the United States and making shipments of said product, there needs to be the exportability information in place.  When shipping, transporting, or moving finished medical devices around inside or outside the United States, the US FDA have full jurisdiction so they need to ensure non-cleared or non-approved devices are making their way into sales channels.  Also, if the company sells other medical devices which are cleared or approved, also quite important because when they check distribution records and seeing products shipped - they need to confirm these are for export only.  Also it depends on the country being shipped to because the company needs to comply with any importing requirements as well - this is part of the Certificate of Exportability process.

Do we need an FDA Certificate of Exportability for exporting investigational IDE-exempt or non-significant risk IVDs into countries that are not on the Tier 1 List at § 802(b)(1)(A)?

Hello Anon,

In most cases yes, because if the product is not cleared or approved in the United States and making shipments of said product, there needs to be the exportability information in place.  When shipping, transporting, or moving finished medical devices around inside or outside the United States, the US FDA have full jurisdiction so they need to ensure non-cleared or non-approved devices are making their way into sales channels.  Also, if the company sells other medical devices which are cleared or approved, also quite important because when they check distribution records and seeing products shipped - they need to confirm these are for export only.  Also it depends on the country being shipped to because the company needs to comply with any importing requirements as well - this is part of the Certificate of Exportability process.

Do we need an FDA Certificate of Exportability for exporting investigational IDE-exempt or non-significant risk IVDs into countries that are not on the Tier 1 List at § 802(b)(1)(A)?