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April 18, 2011
FDA Affirmation of Compliance (AofC) Codes for Medical Devices

On March 24, 2011, the U.S. Food and Drug Administration (FDA) published a letter outlining the kind of information that importers of medical devices should provide to allow the agency to make prompt admissibility decisions on products arriving at designated ports of entry.

In the letter addressed to industry, the FDA outlines specific recommendations to facilitate the import entry review process. These recommendations will directly impact the ability to import medical devices, electronic product components, parts and finished product into the U.S. The agency is asking all companies to ensure that personnel associated with the import processes receive and understand this notification and that procedures are updated accordingly.

Transmission of the necessary information, using the appropriate Affirmation of Compliance (AofC) codes and qualifiers, will help expedite the admissibility process based on FDA's automated screening process and prevent the need to hold the entry for further FDA review. Without the proper information, the FDA may initiate a manual review of each line of entry, which may lead to delays in its release to the importer/consignee.

The letter to the industry and a list of product codes associated with AofC codes are available on the FDA's website at: http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm248321.htm

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