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A single-member LLC with a non-US alien owner wants to sell Class I, 510(k)-exempt medical device via Amazon FBA. The manufacturer of the device is a foreign business entity and has a valid FDA registration. The LLC wants to sell the medical device as private label. The product packaging will reference the LLC as „Manufactured for”. The manufacturer itself will not be referenced on the package.
I would like to understand all the requirements to be fully compliant with FDA and US Customs regulations:
2. If a 3rd party freight forwarder acts as the consignee, do they need their own FDA registration? If so, do they need to have that particular medical device in their Device Listing section of the registration? Do they need to be referenced on the manufacturer’s FDA registration? What FDA roles (as in https://www.fda.gov/medical-devices/device-registration-and-listing/who-must-register-list-and-pay-fee) do they need to be registered for?
3. If the LLC is both the IOR as well as consignee, is it subject to any additional FDA registration requirements?
4. If the LLC wants the device to be packed in boxes with custom artwork and the manufacturer is responsible to print it using their regular supply channel, does it still constitute private label or would it require the LLC to register as Relabeler? To clarify, there is no physical relabeling/repacking activity conducted by the LLC. The LLC merely provides the artwork for the box on the dieline supplied by the manufacturer.
5. What are the factors that would require an Initial Importer to be included in the supply chain? Currently, it seems to me that simply importing a device from a foreign FDA-registered manufacturer as private label makes the LLC a Domestic Distributor and merely requires it to be referenced in the manufacturer’s FDA registration.
6. Per 801.62(m), weight and dimensions should be expanded to the largest whole unit in the following way: „196 in (5 yd 1 ft 4 in)”, which I believe is much less helpful to the end consumer in comparison to „16.4 ft”. Does the latter also satisfy the requirements of FDA labeling regulation? If not, how could „196 in (5 yd 1 ft 4 in)” be simplified?
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Posted by Szymon Krzemiński
Asked on August 12, 2019 6:57 pm
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