FDA

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 […]

QUESTION: I would like to ask the membership –  Under Customs and FDA rules can an Initial importer (FDA Term) and an Importer of record be two separate companies?  If yes, How does this work? What are some common issues? ==================== ANSWER: When I first read this, I thought it said different locations, to which the […]

QUESTION: We are importing a lot of privacy screen products, and marketing team wants to put an Anti-Microbial sticker on the outside of the retail packaging box.  Please see below image for the sticker. We want to know will that be a concern with FDA or EPA? Does anyone think it may be a challenge […]

QUESTION: Seems that many in the community struggle with the FDA’s Intended Use Codes (IUC) when importing a medical device given the import situation.  So if I import a medical device for commercial use, I would use IUC 081.001 and provide the DEV, DFE, LST.  However if I want to import an unapproved medical device […]