The Food and Drug Administration (FDA) issued a final rule on November 29, 2016, establishing requirements for the electronic filing of import entries of FDA-regulated products. Once the rule takes effect, the entries must be made in the Automated Commercial Environment (ACE) in order to be processed by U.S. Customs and Border Protection (CBP). This new rule becomes effective December 29, 2016. 

Under the new rule, certain information must be submitted in ACE at the time of entry in order to facilitate review of FDA-regulated products being imported into the United States. This information is intended to expedite admissibility review by FDA by focusing FDA’s resources on those regulated products that may be associated with a greater public health risk.

When filing an entry in ACE, the filer will need to submit certain product identifying information, such as the FDA country of production, the complete FDA product code and the full intended use code. These data elements are required for all food contact substances, drugs, biological products, human cells and tissue-based products, medical devices, radiation-emitting electronic products, cosmetics, and tobacco products. The rule significantly expands the data requirements for some products. For example, medical devices offered for import must now be accompanied (in ACE) by the facility registration numbers of multiple parties (domestic manufacturer, foreign manufacturer and/or foreign exporter) as well as the device’s listing number (LST). Several of these products also have separate filing requirements, and the new rule does not address or impact those requirements. 

Under the new rule, owners or consignees of imported FDA-regulated goods receive direct notice when FDA intends to take certain actions, for example, sampling articles offered for import. The owner or consignee will have an opportunity to provide information to FDA in opposition to such an action. FDA may reject an import filing for failure to provide complete and accurate information.

The new rule is intended to create a more streamlined import process for FDA-regulated products and to assist FDA in focusing its resources on products that may be associated with a greater public health risk. Submission of the required data elements in ACE will assist FDA in expediting the initial screening and further review of an entry, and can, according to FDA, significantly increase the likelihood that an entry will receive an automated “May Proceed” determination.