FDA Updates the Import Entry Review Process for Medical Devices

Mar 29, 2011   

On March 24, 2011, the U.S. Food and Drug Administrations (FDA) Center for Devices and Radiological Health (CDRH) released a Letter to Industry regarding recommendations to improve medical device import entry review processes in an effort to expedite entry of foreign medical devices into the United States. The Letter to Industry states the Agencys concern with the increasing “number of imported medical devices that do not have sufficient entry data.” The lack of sufficient entry data means more review time for the FDA to make a decision about admissibility at the port of entry. Steven Silverman, Director of the Office of Compliance of CDRH states in the Letter that, “[t]hese recommendations will directly impact your companys ability to import medical devices, electronic product components, parts and finished product into the US.”

When an imported product arrives in the United States, the importer, usually through import personnel (e.g. a broker or filer), must submit certain information electronically to U.S. Customs and Border Protection (CBP). For products regulated by the FDA (or that may be regulated by the FDA), CBP sends the import entry information to the FDA for verification the products meet FDA statutes and regulations. When the information is not submitted correctly or is insufficient, the FDA must initiate a manual review of each line of the entry, which is time consuming and usually leads to delays in entry into the United States.

The FDA is attempting to expedite the admissibility process of imports with the correct Affirmations of Compliance (AofC) and other requested data. Failure to provide adequate AofC data results in manual reviews of product entries. The FDA has published new AofC codes and revised old AofC codes that are to be used when transmitting entries of imported medical devices. Each entry line should contain an AofC code for the following:

¢ Device Foreign Manufacturer (DEV) or Device Foreign Exporter (DFE)
¢ Device Listing (LST)
¢ Device Initial Importer (DII)
¢ Premarket Application (PMA) (can be a PMA, a Humanitarian Device Exemption (HDE), or a Product Development Protocol (PDP) number), a Premarket Notification Number (PMN), or an Investigational Device Exemption (IDE).

The use of AofC codes affirms to the Agency that the product identified in the import entry meets FDAs requirements specific to the product. The AofC codes and their associated descriptions and qualifiers for medical devices can be found in the Appendix to the Letter to Industry. The FDA will provide additional AofC codes as necessary.

The use of AofC codes is voluntary. However, use of the codes will help expedite the entry review process and increase the likelihood that your product is processed on import system screening and not manually.

A second letter will be issued in the future about the import entry review process for radiation-emitting medical electronic devices, such as x-rays, medical lasers, etc. Fuerst Ittleman will continue to monitor the FDA for this announcement.

For information on how Fuerst Ittleman can assist your firm with navigating the import entry review process through CBP and the FDA, please contact us at contact@fidjlaw.com.