FDA

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 […]

QUESTION: Our company wants to import prebiotic soluble fiber from a manufacturer in Europe. It will be imported in the form of a syrup.  Once it arrives in the US, this syrup will be packaging for final customer use in the US. Our scientists have self-classified this product as Generally Recognized as Safe (GRAS) item under […]

QUESTION: Is anyone aware of an HTS Listing, or some other type listing by description, that provides a complete list of items that ARE or ARE NOT subject to FDA?  We import a variety of items and some things we think should flag for FDA do not and other similar items do not flag for […]

QUESTION: Is it required that a US medical device distributor’s FDA registration number be listed under a FDA foreign manufacturer’s device listing number (non-radiation medical devices)?   Example If the foreign medical device manufacturer exports 50 products to the US medical distribution company, does the US medical distribution company have to listed under each individual […]