FDA update – March 26 2011

Letter to Industry about Import Entry Review Process

To all our foreign clients, the FDA has finally decided to notify you about the problems that they (the FDA) has been encountering during your shipments entering the USA ports.

The United States Food and Drug Administration (USFDA), Center for Devices and Radiological Health (CDRH), is increasingly concerned with the number of imported medical devices that do not have sufficient entry data to allow the USFDA to make a prompt admissibility decision at the port of entry into the United States (US).

The purpose of the letter is

• To provide specific recommendations to facilitate the import entry review process.
• To help expedite the admissibility process for submissions that contain the correct Affirmations of Compliance (AofC) and other requested data.
• To increase the likelihood that shipment may be processed based on import system screening and not held for further USFDA entry review.

When an imported product arrives in the US, certain information must be provided/transmitted electronically to the United States Customs and Border Protection (CBP). If the product is or may be regulated by USFDA, CBP sends the import entry information to USFDA for verification to ensure that the product meets USFDA requirements. Without the proper information, USFDA may initiate a manual review of each line of your entry, which may lead to delays in its release to the importer/consignee.

Importers will need to verify that information submitted is correct to ensure the highest level of data quality. For the review of entries to be as quick as possible, consistent and accurate identifiers for firms and correct product codes for the product being imported must be submitted. Inaccurate and/or inconsistent data may lead to delays. CDRH encourages submission of AofC codes along with their appropriate qualifier.

The USFDA has developed new AofC codes and revised old AofC codes appropriate for use when transmitting entries of imported medical devices. Each entry line should contain an AofC code for:

•  Device Foreign Manufacturer (DEV) or Device Foreign Exporter (DFE)
• Device Listing (LST)
• Initial Importer (DII)

Premarket Application (PMA) (Can be a PMA, a Humanitarian Device Exemption (HDE), or a Product Development Protocol (PDP) number) or a Premarket Notification Number (PMN) or an Investigational Device Exemption (IDE).

Additional AofC codes can be provided as considered necessary. Use of these codes affirms that the product identified in a USFDA import entry line meets USFDA requirements specific to the product. Use of these AofC codes is voluntary.

It is imperative that you take the proper actions to avoid unwanted delays.

A second letter will be issued describing the import entry filing process for products subject to both the medical device and electronic product radiation regulations.

For more information on the specific product codes you can go to the following link: http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm248321.htm  or contact mdi at info@mdiconsultants.com Ref: Import Entry Letter.