Question: For FDA regulated imports, what is the relationship between ACE and ITACS. Do you use them in conjunction with each other to better manage compliance for FDA regulated product? Is ITACS supplementary/complimentary to ACE or do these both need to be managed? Answer 1: ACE is used to transmit the entry data to FDA […]
Question: Can anyone provide me with guidance as to how the “AM7 – USDA/Agriculture Marketing Service data related to organics may be required” would apply to things like furniture, bathroom towels/bath mats, and rugs? I’m having a hard time understanding whether I should claim or disclaim this flag. Answer 1: It sounds like your classifications […]
Question: We are about to import diagnostic reagents (3822). These reagents get flagged for FD1 which is no disclaimed and proceed with entities role & AOC information. However, when I get flagged AQ1 and I have a Statement (Guideline 1121) saying products do not require an import permit. Because of statement can I disclaim AQ1? […]
Question: We have 3 medical devices that we send to Mexico for Kitting. These medical devices are not manufactured by us. One device is made in China, second device in Thailand and the third in the USA. All 3 devices have their own HTS classification. This kit is a set. Being new to the company […]
Question: If I am a USA Importer of medical devices, form 7501 Box 26 shows my IOR information. As for Box 25 (UC) would be same as box 26. What if I purchase the goods and tell the foreign manufacturer to ship the goods to another party. I would show the 7501 with my IOR […]
Question: If I am a USA Importer of medical devices, form 7501 Box 26 shows my IOR information. As for Box 25 (UC) would be same as box 26. What if I purchase the goods and tell the foreign manufacturer to ship the goods to another party. I would show the 7501 with my IOR […]
Question: Does anyone have a list of tariff codes that can be disclaimed for FDA? OR any link that provides the info? Asked by: ami mehta – ami.mehta@teradyne.com Answer 1: If you have access to ACE, look for an REF-001 report. Answer 2: Attached is a link to the FDA website. https://www.fda.gov/industry/import-basics/harmonized-tariff-schedule-and-fd-flags Answer 3: PGA […]
Question: Does the FDA allow for a self-disclosure, similar to the way CBP does? Can anyone point me to the FDA regs where it is detailed if in fact it is allowed? Answer 1: You want to be careful here and talk to you company’s legal counsel about this. You did not indicate if this […]
Question: We are looking to import novelty sunglasses and glasses that are part of costumes. They will not offer any type of protection from the sun. Are we able to disclaim FDA on these items? If so, do we have to place a warning label on the packaging? I saw the following in some publications […]
Question: For imported adult products (massagers) that contain lubricant, is FDA required? If so, does it depend on the size of the lubricant pack/bottle that is sold with the product? Answer 1: FDA would definitely be required regardless of lubricant for the massager item. The question about the lubricant is whether its inclusion triggers an […]
Question: Question about FDA data governance between trade compliance and regulatory. In your company (or experience with other companies), does your regulatory group define and provide Affirmation of Compliance codes and related FDA data to the trade compliance group or is your trade compliance group expected to tell regulatory what data elements are required (to […]
Question: TRUE OR FALSE: A factory does not have to register with the FDA if it produces only a ‘component’ for the finished good and the importer does not have to report the component as an FDA item. The added issue is if the component is cleared as the finished good, which definitely is regulated […]
