FDA

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 […]

QUESTION: Can anyone share the FDA Intended Use Code they use for instruments, US origin and originally exported from the United States, being imported back into the US for repair?  The devices may either be repairable or have to be scrapped, but it doesn’t appear there is an Intended Use Code that applies to these […]

QUESTION: If an imported item contains a product that typically comes under FDA but the importing HTS code does not indicate if FDA “is required” or “maybe required” is the importer bound to provide the FDA information anyway or simply to ensure the product is compliance and meets all FDA regulations ? ========== Answers: If […]

QUESTION: We have a new manufacturing plant in Quebec, Canada which sells to customers in AU and NZ under EXW Incoterms.   The customer’s forwarder brings the goods into the US to board a vessel on the US east coast.  I assume they are moving the containers in bond on their own carrier’s bond.  These forwarders […]

QUESTION: We currently import ceiling fans and “normal” light bulbs for the fan in the same box and neither are subject to FDA. Our merchants have made a change and have decided to include LED light bulbs for the fan and LED bulbs are subject to FDA.  The bulbs will be in the same box […]

I know FDA issued clarification that items that contain LED’s such as indictor lights do not require FDA but someone told me that FDA also issued a formal notice clarifying which items containing LED’s would require FDA. ========== Answer: CSMS #17-000330       Title: LIGHT-EMITTING DIODE (LED) REPORTING TO FDA   Date: 6/6/2017 1:43:00 PM   […]

QUESTION: We make and also import Chromatography Columns into the US.  These can be used in many different industries.  At the time of import, for the most part, we will not know who is buying the Chromatography Column after importation.  It is put in inventory and sold.  So, we won’t know the end use at […]

QUESTION: The customs country of origin is based on the API while the FDA country of origin is based on the last manufacturer.   Today I receive the news indicating that “Any party-at-interest may seek judicial review of this determination by Sept 27.   My question is if the pharmaceutical importer can submit any comment […]