FDA at the border: Import and Export Regulations for Medical Devices

by Keith Barritt, Esq, Principal

by Keith Barritt, Esq.

The federal Food, Drug, and Cosmetic Act governs not only the importation of medical devices for sale within the United States, but also the export of devices manufactured in the United States – even if the device is not sold within the United States at all. Parsing through the law applicable to the import, and especially export, of medical devices can be quite difficult. In some cases special recordkeeping and/or notification to the FDA is required, while in other cases prior permission from the FDA is necessary. As the export market becomes more important to U.S. manufacturers, understanding the rules becomes ever more critical.

Importation Of Medical Devices Into The United States

All imports, even if just into customs warehouses, are considered to be “in U.S. commerce” and therefore subject to FDA jurisdiction. The FDA and U.S. Customs and Border Protection work together to determine the legal status of FDA-regulated imports.

Finished Devices

When a finished medical device arrives at a port of entry, the FDA receives an electronic notification of the intended import. The FDA district office either authorizes the import or detains the shipment, issuing a “Notice of FDA Action.” The importer must then submit evidence that the device complies with FDA regulations or offer a plan to bring the device into compliance. If the FDA is not satisfied, it may formally refuse admission, typically giving the importer 90 days to destroy the device or export it out of the United States.

Components And Accessories For Further Processing And Export

Under Section 801(d) of the federal Food, Drug, and Cosmetic Act, importation is permitted under certain conditions of components, accessories, or other articles of a device that do not comply with the Act which are “ready or suitable for use for health-related purposes.” Specifically, the importer must (i) submit a declaration to the FDA of the intent to further process or incorporate the article and then export the device, (ii) maintain certain records regarding the article (the FDA recommends records be kept for five years after exportation), and (iii) destroy or export any imported article that is not properly used. “Further processing” or “incorporation” is not limited to manufacturing, but also includes things such as labeling, packaging, or sterilization.

Export Of Medical Devices Out Of The United States

Export Of Legally Marketed Devices

If a device is “legally marketed” in the United States, it may be freely exported without additional prior FDA authorization or notification, or any special FDA-mandated recordkeeping. To be “legally marketed,” the device must have not only the proper FDA marketing authorization (510(k), PMA, or be 510(k)-exempt), but also be properly labeled and listed with the FDA, and manufactured in compliance with the relevant provisions of the FDA’s Quality System Regulation (“QSR”). Thus, merely having a 510(k) authorization is not necessarily enough, though in most cases the other requirements will be readily met.

Some foreign governments or purchasers may require official confirmation from the FDA that the device being exported is in fact lawfully marketed in the United States. The FDA will issue, upon request and payment of a fee, a “Certification to Foreign Government” confirming the status of the device. The exporter must prepare the CFG for the FDA’s signature, which includes an exporter’s “certification statement” regarding the status of the device and certain additional information regarding the export. A CFG may be issued to a foreign manufacturer for a device that is “legally marketed” in the United States.

Export Of Unauthorized Devices

The 1996 Food and Drug Export Reform and Enhancement Act established three categories of unauthorized devices for purposes of export control, with different regulatory regimes applicable to each.

1. “510(k)-able” Devices (Section 801(e)(1))

To be eligible under this section, the manufacturer must have a “reasonable belief” that the FDA, if asked, would issue a 510(k) authorization for the device. This provision applies where, for whatever reason, the manufacturer does not wish to sell the device in the United States but is confident the device is substantially equivalent to a device that is legally marketed in the United States. The device must also (i) be in accordance with the specifications of the foreign purchaser, (ii) be labeled on the outside of the shipping package “intended for export,” (iii) not be in conflict with the laws of the importing country, and (iv) not be sold or marketed for sale in United States.

The manufacturer must keep records demonstrating that these four criteria are met, and maintain such records for the period of time required under the QSR (i.e. for the design plus the expected life of the device, with a two year minimum from the date of release for commercial distribution). However, no notification to or permission from the FDA is required to export the device.

As with the export of legally marketed devices, some foreign governments or purchasers may request official confirmation from the FDA of the status of the device. The FDA will issue a “Certificate of Exportability” upon certification by the manufacturer that the four export criteria are met. Unlike a CFG, a COE will not be issued to a foreign manufacturer, but may be issued to the U.S. initial distributor.

2. Unapproved PMA And Other High Risk Devices Approved By A “Tier 1” Country (Section 802)

Devices eligible for export under Section 802 must be approved in certain developed (so called “Tier 1”) countries, and include (i) unapproved PMA devices, (ii) devices that are banned by the FDA, (iii) devices that do not comply with an FDA performance standard, (iv) investigational devices, (v) devices intended for further processing pending expected marketing authorization from a Tier 1 country, and (vi) devices intended to treat a tropical disease or another disease not prevalent in the United States (e.g. measles) regardless of Tier 1 approval (subject to FDA approval of the export and provided the device does not present an unreasonable risk). The Tier 1 countries are Australia, Canada, Israel, Japan, New Zealand, Switzerland, South Africa, and members of the European Economic Area.

The export of an eligible device is permitted to Tier 1 countries and other countries that accept Tier 1 authorization if the device meets the four export criteria of Section 801(e)(1) for 510(k)-able devices listed above and (i) is not adulterated, (ii) is not the subject of an “imminent hazard” notice issued by the U.S. government, (iii) is not mislabeled under U.S. law, (iv) is labeled in compliance with the laws of the importing country, (v) complies with laws of importing country, and (vi) substantially meets the QSR requirements. If the importing country does not accept Tier 1 authorization, exports require the approval of both the importing country and the FDA via an “export permit” as an 801(e)(2) export.

Prior permission of the FDA is not required for exports under Section 802. However, the FDA must be notified of any such exports (except for exports to a Tier 1 country for investigational use devices). In addition, records must be maintained regarding the details of each shipment, as well as demonstrate the four export criteria of Section 801(e)(1) set forth above are met.

Upon request, the FDA will issue a “Certificate of Exportability” provided the exporter certifies the export is lawful under Section 802. A COE may be issued to a foreign manufacturer if it has had an acceptable FDA inspection within the last four years.

3. Unapproved PMA And Other High Risk Devices Not Approved by A “Tier 1” Country (Section 801(e)(2))

Devices relegated to export only under Section 801(e)(2) include (i) unapproved PMA devices exported to a country that does not accept marketing authorization from a Tier 1 country, (ii) devices that do not comply with an FDA performance standard exported to a country that does not accept marketing authorization from a Tier 1 country, (iii) banned devices exported to a country that does not accept marketing authorization from a Tier 1 country , (iv) investigational devices intended for use in a non-Tier 1 country, (v) and devices not manufactured in substantial conformance with QSR (regardless of Tier 1 authorization).

Devices exported under Section 801(e)(2) must meet the requirements of Section 801(e)(1) and be issued an “export permit” by the FDA. A request for an export permit must include a complete description of the device, the status of the device in the U.S., and most notably a “letter of acceptance” from the government of the importing country, including a statement of safety review.

To summarize, in general the export requirements boil down to the following (with some exceptions): (i) devices that are authorized by the FDA for marketing in the U.S. may be freely exported; (ii) devices that could be marketed under a 510(k) require only recordkeeping; (iii) devices that could be marketed only under a PMA or are other high risk devices that have been approved by a Tier 1 country require recordkeeping and notification to the FDA; and (iv) devices that could be marketed only under a PMA or are other high risk devices that have not been approved by a Tier 1 country require prior authorization from the FDA.

Exporters of medical devices need to be mindful of what regime applies to their devices, as they may otherwise find themselves surprised to be in violation of FDA law even without selling any devices within the United States.