Compliance Notes

by Anna Longwell, Esq.

Compliance Note: Device Export

The Law

In 1996, Congress passed the FDA Export Reform and Enhancement Act. This law had several purposes, 1) Facilitate world trade, 2) Expedite FDA authorization to export, 3) Ease restrictions on export of unapproved FDA products, and 4) Satisfy foreign government requirements. It also empowered FDA to collect fees for providing certificates testifying to the legality of exporting products under FDA jurisdiction.

Basically, export is interstate commerce, and FDA has jurisdiction over health care products in interstate commerce. Prior to the new law, FDA had regulated the export of devices under section 801 of the FDCA, and this portion of the law is still in effect. Under 801(e)(1), medical devices that do NOT need a PMA to be sold in the US (e.g. 510(k) or exempt devices), are exempt from provisions of adulteration or misbranding if several conditions are fulfilled. These are 1) the product must comply with the specifications of the foreign purchaser, 2) it is not in conflict with law in the destination country, 3) the shipping carton is labeled “for export only”, and 4) the product has not been offered in domestic commerce.

While 801 does not explicitly exempt from 301(p), which makes failure to provide information required by section 510(k) a prohibited act, FDA has chosen to interpret 801 and 301(p) such that 801 provides exemption from 510(k) notification as well. Section 801 also provides for export of PMA products, but only if such products obtain a permit for export from FDA.

The new law offered much simpler ways to export PMA products, and is set forth in section 802. Briefly, an American manufacturer may export to any country if the product is approved in a listed country, and only notification to FDA, not permission, is required. The manufacturer must maintain records, and the product must be labeled according to requirements of both importing country, and listed country. Such products cannot be adulterated because of “filth”, and must be made in substantial compliance with US device QSR, or ISO quality standards. Additionally, the conditions for export of a non-PMA product listed in 801, must be fulfilled. A listed country is one which has controls recognized by Congress (or FDA), to ensure the safety of health care products sold within its borders. The law listed Australia, Canada, Israel, Japan, New Zealand, Switzerland, South Africa, and EEA (Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, and United Kingdom), and it provides that FDA may add to this list.

Additionally, in section 802(c), product requiring a PMA for commercial US sale, but exported for investigational use, may be exported to listed countries in accordance with their law, without an IDE.

As required by the 96 law, FDA provides several certificates to exporters. (Although FDA did provide similar certificates prior to 96, there was no requirement that they do so). These are certificates to governments attesting to products’ compliance status in the US. Some foreign customers will request these certificates. The Certificate to Foreign Governments indicates that the product is legally marketed in US, and therefore, may be legally exported. The Certificate of Exportability (Section 802), indicates that the product would need a PMA/PDP for sale in the US, and does not have one, or that the product is under IDE in US, but it can be exported legally. The Certificate of Exportability (Section 801(e)(1), indicates that product needs a 510(k) for sale in US, does not have one, but is legally exportable. Finally, it is still possible to get an export permit for a PMA product under 801(e)(2), should it be necessary to export a PMA product to an unlisted country without marketing permission from a listed country.

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