FDA

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 […]

QUESTION: We have a situation where our foreign vendor imports into a bonded warehouse (which is run by a 3PL) and we withdraw product as needed. We are not their only customer that withdraws from this bonded warehouse. The products we withdraw, for our purposes, are FDA regulated.  As I understand the requirements, any FDA […]

QUESTION: If Corporation A owns Divisions 1, 2, and 3 and Divisions 1, 2, and 3 import goods is it compliant for Corporation A to be declared as Device Initial Importer for the shipments imported by Divisions 1, 2, and 3? ========== Answers: There is some details missing here thus I’m making some assumptions in […]

QUESTION: FDA recently initiated FDA filing requirements for non-medical LED products. Unfortunately, the tariffs are not yet flagged for FDA but we are still being required to file the FDA info.   How are you / your broker reporting?   Also, would you think just one LED is reportable? ========== Answers: LED lights can be […]

QUESTION: Our company imports 100’s of raw materials needed to manufacture FDA Regulated Medical Devices. Many of the raw materials 7have HTS numbers that do not flag for FDA, and are items that would not normally be under FDA’s authority, such as air or liquid pumps, stepper motors, aluminum or steel cabinet panels and brackets. […]

QUESTION: I was told by our customs broker that new Regulations are in effect by the FDA on 2/2 impacting items classified under HTS: 8541.20.2000. I was told that this HTS will require FDA filing?  Has anyone heard/read anything about it?  I can’t validate this information to implement such changes. ========== Answers: I am having […]