FDA Issues Letter to Industry Regarding Imports of Medical Devices

Sep 20, 2011   

On September 6, 2011, the U.S. Food and Drug Administration (FDA) issued a Letter to Industry focused on the import entry review process. Importers of medical devices are encouraged to provide sufficient documentation in order to avoid time-consuming FDA review of each line offered for entry. Found here, the Letter sets forth several recommendations to importers of medical devices aimed at expediting the importation process. For instance, the FDA sets forth the various categories of medical devices that are subject to federal performance standards, noting that importers must provide a form certifying that the devices offered for import conform to these standards. The Letter, which is a follow-up to a March 24, 2011 letter published by the FDA, also reiterates the importance of using Affirmations of Compliance (AofC) codes.

Found here, the March 24, 2011 Letter to Industry regarding the import entry review process details the benefits of using AofC codes, including how they will expedite the importation process. AofC codes are specific identifiers of FDA-regulated products that may be used by importers to certify that the line offered for import meets the requirements of the particular code. Generally, when FDA-regulated goods are offered for import into the country, U.S. Customs and Border Protection (CBP) forwards import entry information to the FDA in order to verify that the goods meet all necessary FDA regulations. The FDA warns that without proper documentation, including the use of AofC codes, the review process will often be delayed, as FDA may have to undertake a manual review of the entry. Because of the complexities of the importation process, particularly when FDA-regulated goods are involved, importers should be aware of the various means of expediting the review process in order to avoid unnecessary set-backs upon entry.

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