FDA COMPLIANCE

Filers must use ACE to file shipments regulated by the Food and Drug Administration (FDA)

The U.S. Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. Starting June 15, 2016, FDA will also require electronic transmission of data and new data elements to be reported as well.

Effective May 30, 2017, there are additional FDA data required for food importation to comply with the Foreign Supplier Verification Program (FSV) under the Food Safety Modernization Act (FSMA). For each food product offered for importation into the US, the following information must be included for the US owner or consignee: DUNS number; Company Name and Address; Contact email and Optional additional elements. In the absence of a U.S. owner or consignee, the importer must provide the information for an agent or representative. For more details and exemptions, please visit FSMA and read our FAQ document.

What’s changing under ACE

When ACE came into effect, data is no longer accepted via ACS; all electronic data must be transmitted through ACE.

New required data elements concerning FDA regulated products include government agency processing codes to tell the FDA more about the item’s product category; Affirmations of Compliance, to help screen products; and intended use statements, to help identify a products’ end-use.

These additional requirements will allow FDA’s reviewing system, PREDICT, to expedite the screening of FDA imported products by determining which entries are higher and lower risk. Lower risk shipments will receive “MAY PROCEED” without FDA examination status while higher risk shipments may require further “FDA REVIEW”.

Looking for more detailed information?

FDA government agency processing codes
FDA Affirmations of Compliance
FDA Intended Use
FDA data elements guide

The right product data. At the right time.

Under ACE, it’s imperative that you provide your customs broker with the right FDA-related information to ensure your information is captured correctly – and your shipments meet their ACE obligations.

Livingston has developed a series of forms that can be used by new and existing clients to set up a proper database. This process only needs to be done once at the initial setup stage to ensure ongoing compliance. Be proactive. Start your ACE compliance today!

FDA – Biologics
FDA – Electronics
FDA – Medical Devices
FDA – Cosmetics
FDA – Food
FDA – Tobacco
FDA – Dietary Supplements
FDA – Food Related Items
FDA – Veterinary
FDA – Drugs

Trust the FDA experts at Livingston

No one understands the FDA’s import requirements better than Livingston. With a dedicated FDA compliance team and a full staff of U.S. regulatory affairs experts, we know the FDA inside and out.

In addition, we’ve spent months getting ACE-ready. Our people, processes and technology are in place and ready to support existing and new clients, whatever their FDA or ACE needs.