2005N-0190 Agency Information Collection Activities; Proposed Collection; Comment Request; Export of FDA Regulated Products Export Certificates
FDA Comment Number : EC1
Submitter : Mr. Brian von Gunten Date & Time: 07/15/2005 05:07:28
Organization : Block Imaging International
Category : Device Industry
Issue Areas/Comments
Guidance for Industry, FDA Export Certificates (July, 2004) mentions that firms exporting medical devices are often asked by customers or foreign governments to supply certifications that the equipment meets U.S requirements. U.S. Distributors are also asked to provide FDA certificates for devices that they are shipping, even if the device is not actually crossing US borders.

As an FDA-recognized distributor, we recently attempted to ship a medical device (approved for marketing in the US) from the manufacturing facility in Japan to our customer in Argentina. We requested a FDA Certificate to Foreign Government (as did the manufacturer who named us as their distributor) to establish that the device may be legally marketed in the USA (and thus in Argentina). Our request for the certificate was denied; FDA's reason for the denial was 'based on the (sic) product listed in your request are (sic) not exported from the United States.'

The requirement that the device actually be exported from the U.S. was not present in previous guidance nor is it required by statute or regulation. The change severly restricts US distributors from pursuing foreign business opportunities.

In our case, we were not asking FDA to state that the device would be exported from the U.S. Rather, we were only asking the FDA to document that this particular model of medical device may be legally marketed in the U.S. The Federal Register (September 9, 2002) describes that 'Certificates to Foreign Governments' are issued for legally marketed products that are in compliance with the requirements of the Act. Further, Section 801(e)(4) of the Act provides that 'FDA shall, upon request, issue certificates for devices that either meet the applicable requirements of the Act and may be legally marketed in the United States OR may be legally exported from the United States'. We note that the Act does not allow the FDA to deny issuance or retract a certificate if the device is not actually exported during the two-year life of the certificate.

There is also some question about FDA's definition of export. Even for shipments that do not cross US borders, US Principle Parties in Interest (USPPI) are required to issue a Shipper's Export Declaration with US Customs. One branch of the US government considers a USPPI's shipment from foreign country to foreign country an export, while FDA's definition is to the contrary.

We propose that the FDA also issue Certificates to Foreign Government to US Distributors for medical devices shipped anywhere in the world, as long as the device can be legally marketed in the U.S.