FDA

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 […]

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 […]

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 […]

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 […]

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 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 looking to consolidated FDA with Non-FDA cargo into a single container booked directly with the carrier and not through a traditional forwarder/NVOCC in order to reduce cost. We are being told by a supplier that this is not a good practice and it is better to split and ship separately in the […]

QUESTION: We recently had an import shipment of LEDs that required FDA reporting and we marked form 2877 as A5 (Are not subject to radiation performance standards because they are components or sub-assemblies to be used in manufacturing or as replacement parts.) The instructions for declaration A state “components or sub-assemblies must be non-functioning”. What […]