Questions and answers about FDA


    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 […]

  • FDA Entities Data Applicable to Components

    QUESTION: Is the manufacturer’s name and address considered required entity information for FDA clearance for components under CPT? NOTE, by manufacturer I am referring to a raw material/component manufacturer who is NOT required to register and list Feedback from the FDA import desk referred me to the FDA Supplemental Guide but for “devices”, not components […]

  • Products that need registered with FDA?

    QUESTION: Is a UV Air Purifier required to be registered with the FDA? As well as the facility they are distributing from? These are making claims that they destroy so much of a bacteria level. Other questions are the filters for the UV Air purifier required to be registered with the FDA, especially if they […]

  • Importing Masks

    QUESTION: If there are other companies that imported disposable face masks, can you please share the FDA product code? Thanks in advance !! %%%%%%%%%% ANSWERS: FDA Code is 80Q–KR.  If they are non-medical grade and for standard use then use code 081006. %%%%%%%%%% We used 80F—XX and intended use code 940.00 %%%%%%%%%% There is no […]


    QUESTION: I am looking to find out if the N95 Cone respirators are regulated by FDA. These are the face masks to fight out the Coronavirus. ========== Answers: Yes! If being imported for internal use and not resale, you do not need registration but they must come from a registered manufacturer and you will still […]

  • FDA IFE-Import For Export

    QUESTION: I am stumped. If I were to use the FDA’s Import For Export (IFE) program I would use the Intended Use Code of 970.001. One of the mandatory Affirmation of Compliance is LST (Device Listing Number), but the product is not listed with the FDA, so if I do not have an LST, the […]


    QUESTION: We are importing syringes that are used in labs to transfer sample fluid from one tube to the next. These are not used to inject people or humans. Our customs broker advised us that we are still required to classify under 9018.31.0080. Using this HS Code flags for FD2 and AOCs. Is that correct, […]