(World Trade Interactive)
Responding to increasing concerns with the number of imported medical devices that do not have sufficient entry data to allow prompt admissibility decisions at U.S. ports of entry, the Food and Drug Administration issued to industry members last week a letter providing specific recommendations designed to facilitate the import entry review process for these goods. It is essential, FDA states, that the appropriate personnel associated with the import process (e.g., regulatory affairs, import personnel, brokers/filers, etc.) receive and understand this information and that individual company procedures are updated accordingly.
The letter explains that when an imported product arrives in the U.S., certain information must be provided or transmitted electronically to U.S. Customs and Border Protection. If the product is or may be regulated by FDA, CBP sends the import entry information to FDA for verification to ensure that the product meets FDA requirements. Without the proper information, FDA may initiate a manual review of each line of an entry, which may lead to delays in its release to the importer or consignee.
To increase the likelihood that shipments will be processed based on import system screening and not held for further entry review, FDA recommends the submission of not only consistent and accurate identifiers for firms and correct product codes for the products being imported but also affirmations of compliance (AofC) codes along with their appropriate qualifier. FDA has developed new AofC codes and revised old ones appropriate for use when transmitting entries of imported medical devices, and the letter contains an appendix listing AofC codes with their associated descriptions and qualifiers for medical devices. According to FDA, 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), premarket notification number (PMN) or investigational device exemption (IDE)
FDA emphasizes that the use of these codes affirms that the product identified in an FDA import entry line meets FDA requirements specific to the product.
Date: March 31, 2011