Questions and answers about FDA

  • Adult products containing lubricant

    Question: For imported adult products (massagers) that contain lubricant, is FDA required?  If so, does it depend on the size of the lubricant pack/bottle that is sold with the product? Answer 1: FDA would definitely be required regardless of lubricant for the massager item. The question about the lubricant is whether its inclusion triggers an […]

  • FDA Data / Clearance Process

    Question: Question about FDA data governance between trade compliance and regulatory. In your company (or experience with other companies), does your regulatory group define and provide Affirmation of Compliance codes and related FDA data to the trade compliance group or is your trade compliance group expected to tell regulatory what data elements are required (to […]

  • Factory / importer registration for a component

    Question: TRUE OR FALSE: A factory does not have to register with the FDA if it produces only a ‘component’ for the finished good and the importer does not have to report the component as an FDA item. The added issue is if the component is cleared as the finished good, which definitely is regulated […]

  • FDA Update not in Reject Status

    QUESTION: Is it possible to update FDA information that has been accepted and not in reject status within the US Customs Entry without cancelling/deleting the entry and resubmitting another entry? The scenario is information is entered for the entry, the shipment crosses the border.  Once the shipment is in the US, the shipment is verified.  […]

  • FDA for stainless steel water bottles

    QUESTION: Is FDA required for imports of stainless steel water bottles, HTS code 7323.93.0080?  This is a new commodity for us, and I was previously advised that anything that holds food or drink is subject to FDA.  If so, can anyone share the FDA product code? ========== Answers: Here is the link to the FDA […]


    QUESTION: Does anyone in the membership have a training they can share for FDA requirements for Customs? I’m looking to put together a training in the next week to cover import requirements for Customs when they are flagged for FDA. =========== Answer: FDA can hold a shipment for many reasons. Usually, they are checking for invoice […]


    QUESTION: We operate in MX under Maquiladora License (IMMEX). I have FDA subject products made in MX – Catheters for Intravascular, Diagnostic. The catheters were sold to a customer in India and are not being returned to the customer under RGA (Return Goods Authorization). The Shipper/Exporter in India does not have an FDA registration. Can […]


    QUESTION: One of our employees in Mexico is shipping his laptop computer to our facility in the United States.  The HTS,  8471.30.0100, is flagging as FD1.  Can the FDA be disclaimed or do we need to submit form 2877 and determine a product code? Where can this information be found? ========== Answers: Flag Meaning Examples […]

  • Answers to Question on FDA Initial Importer

    QUESTION: Our company imports medical devices. Since we import all, we are the IOR. I do not understand whether we are also considered the initial importer under FDA. We occasionally repackage items to send to domestic customers. We are FDA registered for various devices as specification developer or complaint file established. Are we considered to […]


    QUESTION: What is the best practice when submitting the Affirmation of Compliance code? Is having the AofC code for each commodity onto the commercial invoice sufficient for the import clearance review? =========== Answer: No, that is the wrong place to submit the data.  To be fair, you can them on your docs if you like, […]


    QUESTION: We have goods imported (HTS 9018.49.8080- component to ceramic bracket) and is stuck with customs and no one is able to help for the last week.  Per 21CFR 807.85- We are exempt from FDA registration as the goods are components used in the manufacturing of a medical device.  Does anyone have any advise if […]

  • Determining FDA Medical Device

    QUESTION: Has the membership had experience importing general wellness and aromatherapy products that claim therapeutic healing? Products such as essential oils, diffusers, beaded neck pillows and eye masks, etc. Determination of a medical device is largely based on intended use, packaging and marketing. Requirements for importing medical devices regulated by the FDA are vastly different […]